Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 9721–9740 of 38,428 recalls

October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AC3 Optimus Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT 2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AC3 Optimus Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT 2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AC3 Optimus Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AC3 Optimus Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
October 17, 2022· ARROW INTERNATIONAL Inc.

Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump

The Issue: There is a potential issue with short battery

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing