Implantable Defibrillators Recalled: Potential Therapy Energy Delivery Failure
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The recall affects approximately 6,536 units with a specific feedthrough component.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall with potential for failure of high-voltage therapy delivery in implanted cardioverter defibrillators and cardiac resynchronization therapy defibrillators. The agency's Class I classification establishes a minimum severity threshold of 4.
Plain-English summary
Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component. Specifically affected is model DTMB2D1 AMPLIA MRI OUS DF1. These devices have a rare potential for reduced or no energy output during high-voltage therapy, which is typically administered at 0-12 joules.
The recall involves approximately 6,536 units that were distributed nationwide and worldwide. The potential for therapy energy failure could prevent the device from delivering its critical life-saving treatment function.
Patients implanted with an affected device should contact their physician or Medtronic immediately to verify whether their specific device serial number is included in the recall. The FDA and Medtronic have provided detailed lot and serial number information to help identify affected units. Your healthcare provider can determine whether device replacement, reprogramming, or other action is necessary.
The recalled product
- Product
- CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- energy-delivery-failure
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00643169837645
- Lot Serial numbers: RPQ605053S
- RPQ606292S
- RPQ605067S
- RPQ605093S
- RPQ601699S
- RPQ605875S
- RPQ605881S
- RPQ601451S
- RPQ602698S
- RPQ605503S
- RPQ606300S
- RPQ601185S
- RPQ601351S
- RPQ601948S
- RPQ601950S
- RPQ602093S
- RPQ602202S
- RPQ602212S
- RPQ602402S
Distribution
Distributed nationwide across the United States.
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