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 8261–8280 of 38,428 recalls

May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD-DR DDMB1D1 EVERA MRI XT US DF1

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD-VR DVEX2E4 EV ICD OUS EV4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD-VR VISIA MRI AF XT OUS DF4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD-VR VISIA AF XT OUS IS1/DF1

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CRTD DTMB2D4 AMPLIA MRI OUS DF4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CRTD DTMA1QQ CLARIA MRI QUAD US DF4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CRTD COBALT XT HF QUAD MRI IS4 DF4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CRTD DTMB1QQ AMPLIA MRI QUAD US DF4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD COBALT VR MRI DF4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CRTD DTPA2D1PX COBALT XT HF QUAD OUS

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CRTD COBALT XT HF MRI IS1 DF1

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD EVERA XT DR GOLD CTD

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD CROME VR MRI DF4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD COBALT XT VR MRI DF4

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing
May 10, 2023· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: ICD-VR DVAB1D1 VISIA AF US IS1/DF1

The Issue: There is a rare potential for reduced- or

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

Class I — Serious Health HazardOngoing