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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recalls

All product recalls associated with Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF).

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 5161–5180 of 21320 recalls

Cobalt Implantable Cardioverter Defibrillator (Medtronic) – Reduced Shock Energy (2022)

There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Moderate

FDAJun 22, 2022Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

AquaC UNO H (Fresenius) – Ethernet Cable Ferrite Core Missing (2022)

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

Moderate

FDAJun 21, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

AquaC UNO H Reverse Osmosis Unit (Fresenius) – Electromagnetic Compatibility Issue (2022)

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

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Moderate

FDAJun 21, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Esomeprazole Magnesium 20mg Capsules (Sun Pharma) – Superpotent Drug (2022)

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Class IIILow

FDAJun 21, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Testosterone Cypionate Injection (Sun Pharma) – Water Leakage (2022)

cGMP - Water leakage

Class IIModerate

FDAJun 21, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Esomeprazole Magnesium 40mg Capsules (Sun Pharma) – Superpotent Drug (2022)

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Class IIILow

FDAJun 21, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Merlin 2 PCS Programmer (St. Jude Medical) – Programming System Design (2022)

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

Low

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

Merlin PCS Programmer (St. Jude Medical) – Software Display Error (2022)

There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

Low

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

Merlin.net Software (St. Jude Medical) – Programming System Design (2022)

Low

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

Neurology Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Laparoscopy Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Breast Abdominoplasty Pack (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

D&C Pack (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Convenience Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

PICC Line Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Pacemaker Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

AquaC UNO H Reverse Osmosis Unit (Fresenius) – Ethernet Cable Risk (2022)

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

High

FDAJun 16, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

C-Section Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

Angiography Packs (American Contract) – Sterilization Cycle Concern (2022)

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Moderate

FDAJun 16, 2022Nationwide• American Contract Systems, Inc.

NordicBrainEX Software (NordicNeuroLab) – Export Results Error (2022)

When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.

Moderate

FDAJun 16, 2022Nationwide• NordicNeuroLab AS Mollendalsveien 65c Bergen Norway