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 8241–8260 of 38,428 recalls

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

Recalled Item: CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD

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 DVME3D1 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: CRT-D DTBB2QQ VIVA QUAD S IS4/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 COBALT XT 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: ICD-DR DDME3D1 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-DR DDMC3D4 EVERA MRI S IS-1/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 COBALT XT 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: CRTD DTMA2Q1 CLARIA MRI QUAD 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: CRTD DTMA2QQ CLARIA 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: CRTD DTMB2QQ AMPLIA 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 DVMB2D1 EVERA 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: CRT-D DTBA1QQ VIVA QUAD XT 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 COBALT DR MRI IS1 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 DTMB1D1 AMPLIA MRI 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: CRT-D DTBC2D4 BRAVA 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: CRT-D DTBA2Q1 VIVA QUAD XT 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: CRTD COBALT 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: CRT-D DTBA1D1G DF1 VIVA XT US 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-VR VISIA 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 DDPA2D4G COBALT XT DR MRI DF4 GOLD

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