Facility

Lutonix, Inc.

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

Key facts

49recalls · worst Class I

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006513822
Establishment type	Manufacture Medical Device
Location	1625 West 3rd Street Tempe, AZ, US 85281
Registration status	Active · expires 2026
Parent company	C. R. Bard, Inc. (owner-operator 2212754)
Brand names	Lutonix Drug Coated Balloon; Lutonix 018 Drug Coated Balloon PTA Catheter; Lutonix 035 Drug Coated Balloon PTA Catheter

Activity by year

Recalls (49)
Inspections (1)

Devices registered here (1)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Product code ONU (opens in a new tab) · Class III · Unknown

Recalls & enforcement

20262 records

Class IIOngoing2026-06-25
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Class IIOngoing2026-04-23
Due to stain present on the surface of affected foley catheters.

20255 records

Class IIOngoing2025-11-06
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Class IIOngoing2025-07-17
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone …
Class IIOngoing2025-06-18
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Class IIOngoing2025-06-03
Cather packaging may contain the incorrect French size.
Class IOngoing2025-04-17
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

20241 record

Class IIOngoing2024-05-09
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

20233 records

Class IIOngoing2023-12-20
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Class IIOngoing2023-11-15
BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hou…
Class IIOngoing2023-04-20
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

20222 records

Class IIOngoing2022-05-19
Complaints relating to urine output measurement accuracy.
Class IITerminated2022-01-27
There is a potential to leak from the catheter where it connects to the drain bag

20212 records

Class IIOngoing2021-08-05
There is potential for packaging defects that may impact the sterile barrier.
Class IITerminated2021-01-11
The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

20202 records

Class IITerminated2020-04-15
There is potential for a white paper-type residue attached to the catheter.
Class IITerminated2020-01-13
Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic …

20181 record

Class IITerminated2018-02-27
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.

201711 records

Class IITerminated2017-12-13
Foley Catheter with Incorrect Retainer Cap Print
Class IITerminated2017-11-10
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
Class IIOngoing2017-11-10
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
Class IITerminated2017-10-16
Hydrogel peeling from the pads.
Class IITerminated2017-09-29
The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
Class IITerminated2017-09-14
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Class IITerminated2017-07-28
Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
Class IIIOngoing2017-06-02
Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
Class IITerminated2017-06-02
Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
Class IIOngoing2017-03-31
Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
Class IICompleted2017-03-09
Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

201612 records

Class IITerminated2016-12-09
Activity and quantity of seeds sent in shipments were incorrect.
Class IITerminated2016-10-13
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Class IITerminated2016-10-12
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Class IITerminated2016-10-12
Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
Class IITerminated2016-10-05
Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).
Class IITerminated2016-08-03
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Class IITerminated2016-07-11
The product contained a latex catheter instead of a silicone catheter.
Class IITerminated2016-07-11
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Class IIITerminated2016-06-30
An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
Class IIITerminated2016-06-29
Labeling problem
Class IITerminated2016-03-04
Complaints were received of restricted/inaccurate flow rate.
Class IIITerminated2016-01-04
Report by a customer of an open package seal.

20157 records

Class IITerminated2015-12-18
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Class IITerminated2015-11-10
Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
Class IITerminated2015-11-09
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device …
Class IIITerminated2015-10-02
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
Class IITerminated2015-08-24
Potential breach of the sterile barrier packaging.
Class IITerminated2015-07-07
Potential breach of the sterile barrier packaging.
Class IITerminated2015-01-30
Potential breach of the sterile barrier packaging.

20141 record

Class IITerminated2014-10-07
The product is non-sterile.

FDA inspections (1)

NAI2017-05-24
No Action Indicated · Bioresearch Monitoring

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.

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. “Lutonix, Inc. (FEI 3006513822) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006513822-lutonix-inc/

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