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 8181–8200 of 38,428 recalls

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

Recalled Item: ICD-DR DDBB2D4 EVERA XT IS1/DF4 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 CROME VR 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: CRT-D DTBA1D1 VIVA XT IS1/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: CRTD DTMC2QQ COMPIA MRI QUAD 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 DVME3D4 MIRRO MRI

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 DVFB2D1 VISIA AF MRI XT OUS 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 VISIA MRI AF S US/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-DR DDMD3D4 PRIMO MRI

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 DTBB1QQ VIVA QUAD S IS4/DF4 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-VR DVBC3D4 EVERA 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 DTBC2D1 BRAVA IS1/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 DVMB1D4 EVERA MRI XT DF4 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-DR DDME3D4 MIRRO MRI

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 DTMA1Q1 CLARIA MRI QUAD 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 DVMB2D4 EVERA MRI XT DF4 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 DVBB2D1 EVERA XT IS1/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 DVBB2D4 EVERA XT DF4 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-DR DDMD3D1 PRIMO MRI

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 CROME HF QUAD MRI IS4 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 VISIA AF S US/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