RegWardenFDA facility compliance records
Facility

Greatbatch Medical S. de R.L. de C.V.

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

Activity by year

FDA actions on record by year2012: 3 recalls; 2013: 2 recalls; 2014: 2 recalls; 2016: 5 recalls; 2017: 2 recalls; 2023: 1 inspections3’122’132’14’155’162’17’18’19’20’21’221’23’24’25’26
  • Recalls (14)
  • Inspections (1)

Devices registered here (1)

  • Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
    Product code HWE (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4820

Recalls & enforcement

20172 records
  • Class IITerminated2017-04-23
    Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the …
  • Class IITerminated2017-02-15
    One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
20165 records
  • Class IITerminated2016-11-11
    Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
  • Class IITerminated2016-10-19
    On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate fo…
  • Class IITerminated2016-09-08
    Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.
  • Class ITerminated2016-08-02
    On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use …
  • Class IITerminated2016-04-26
    Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles…
20142 records
  • Class IITerminated2014-04-28
    Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
  • Class ITerminated2014-01-31
    Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6…
20132 records
  • Class IITerminated2013-05-31
    Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.
  • Class IITerminated2013-01-16
    Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45® product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.
20123 records
  • Class IITerminated2012-11-12
    Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like li…
  • Class IITerminated2012-09-24
    We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the Mo…
  • Class IITerminated2012-09-06
    During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.

FDA inspections (1)

  • NAI2023-02-10
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “Greatbatch Medical S. de R.L. de C.V. (FEI 3011823740) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011823740-greatbatch-medical-s-de-r-l-de-c-v/

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