RegWardenFDA facility compliance records
Facility

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

57 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2013: 3 recalls; 2014: 5 recalls; 2015: 4 recalls; 2016: 6 recalls; 2017: 6 recalls; 2018: 5 recalls; 2019: 3 recalls; 2020: 5 recalls; 2021: 2 recalls; 2022: 4 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 7 recalls; 2026: 5 recalls3’135’144’156’166’175’183’195’202’214’221’231’247’255’26
  • Recalls (57)

Devices registered here (1)

Recalls & enforcement

20265 records
  • Class IIOngoing2026-07-13
    Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
  • Class IIOngoing2026-06-16
    For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without …
  • Class IIOngoing2026-05-27
    A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop…
  • Class IIOngoing2026-02-13
    All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational…
  • Class IIOngoing2026-01-30
    Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either…
20257 records
  • Class IIOngoing2025-11-13
    When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is d…
  • Class IIOngoing2025-11-02
    A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
  • Class IIOngoing2025-10-21
    Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
  • Class IIOngoing2025-06-16
    Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dos…
  • Class IIOngoing2025-05-07
    The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
  • Class IIOngoing2025-03-04
    Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user …
  • Class IIOngoing2025-01-31
    All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin,…
20241 record
  • Class IOngoing2024-07-31
    Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increa…
20231 record
  • Class IIOngoing2023-11-15
    Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact…
20224 records
  • Class IIOngoing2022-11-21
    An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hype…
  • Class IIOngoing2022-09-20
    Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin t…
  • Class IIOngoing2022-05-23
    Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
  • Class IIOngoing2022-01-27
    New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead…
20212 records
  • Class IIOngoing2021-03-15
    Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over deliver…
  • Class IIOngoing2021-02-26
    Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
20205 records
  • Class IIOngoing2020-11-12
    Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insul…
  • Class IITerminated2020-07-15
    As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
  • Class IIOngoing2020-04-30
    Missing solder battery connection, which could interrupt power of insulin pump.
  • Class IITerminated2020-04-10
    Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacido…
  • Class IIOngoing2020-01-28
    Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen
20193 records
  • Class IOngoing2019-11-21
    There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or…
  • Class IIOngoing2019-06-27
    The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change…
  • Class IIOngoing2019-05-20
    Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) af…
20185 records
  • Class IIOngoing2018-10-03
    Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and lo…
  • Class ITerminated2018-08-07
    There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
  • Class IITerminated2018-07-04
    The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
  • Class IITerminated2018-05-16
    CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.
  • Class IITerminated2018-04-24
    The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen, which allows user to program alerts that will sound if users are predicted to reach their pre-set low or high s…
20176 records
  • Class IITerminated2017-10-10
    Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that use…
  • Class IIOngoing2017-09-10
    Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
  • Class IITerminated2017-05-08
    Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
  • Class IITerminated2017-05-03
    Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
  • Class IITerminated2017-02-08
    Handle may break during use.
  • Class IITerminated2017-01-31
    Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.
20166 records
  • Class IITerminated2016-10-04
    Product sterility is compromised due to breach of the sterile barrier
  • Class IITerminated2016-08-05
    Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
  • Class IITerminated2016-07-08
    Potential for compromise of the package resulting in a breach of the sterile barrier
  • Class ITerminated2016-04-13
    Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.
  • Class IITerminated2016-04-01
    Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm
  • Class IITerminated2016-02-19
    Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The C…
20154 records
  • Class IITerminated2015-12-02
    Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
  • Class IITerminated2015-09-25
    The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
  • Class IITerminated2015-07-22
    Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish …
  • Class IITerminated2015-06-19
    Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.
20145 records
  • Class IIITerminated2014-11-10
    The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.
  • Class IITerminated2014-11-04
    Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to hyperglycemia, and diabetic ketoacidosis (DKA).
  • Class IITerminated2014-07-21
    Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.
  • Class IITerminated2014-06-16
    Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device.
  • Class IITerminated2014-03-13
    Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.
20133 records
  • Class IITerminated2013-07-03
    Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than int…
  • Class ITerminated2013-06-07
    Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Un…
  • Class IITerminated2013-03-22
    Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it may result in damage to the pump's internal electronics.…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS (FEI 3042027705) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3042027705-medtronic-puerto-rico-operations-co-junc/

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