Severe FDA (Devices)·Z-1765-2023·Announced 2023-06-28

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)
Category: Medical Device — Implantable Cardiac Devices
Hazard: therapy-failure
energy-delivery-failure
device-malfunction
Affected units: 6,536

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.

Part of a larger recall action

This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 120 products in this recall →

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

See all →

Critical
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
Severe
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28

Same hazard · therapy failure