Agency classClass IOur severity:Severe FDA (Devices)·Z-1816-2023·Announced 2023-06-28

Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

Medtronic recalls certain ICD and CRT-D defibrillators due to a rare potential for reduced or no-energy output during high-voltage therapy. Affected devices were manufactured with a specific glassed feedthrough component.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity of 4. Although no illnesses have been reported and the defect is described as rare, the underlying hazard involves potential failure of critical lifesaving defibrillation therapy delivery.

Plain-English summary

Medtronic is recalling certain ICD-VR DVME3D1 MIRRO MRI implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high-voltage therapy. The devices were manufactured with a specific glassed feedthrough component that may be affected.

The defect may result in the device delivering insufficient or no energy during defibrillation therapy, which typically ranges from 0 to 12 joules. Approximately 3,852 units have been distributed nationwide and worldwide. The recall includes multiple serial number lots manufactured with the affected feedthrough design.

Patients with affected ICDs or CRT-Ds should contact their healthcare provider or Medtronic to determine if their device is part of this recall. Device identification can be confirmed by checking the serial number against the provided lot list. Do not discontinue use of your device without consulting your physician.

The recalled product

Product: ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Defibrillators
Hazard: device-malfunction
therapy-failure
Affected units: 3,852

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 00763000001605
Lot Serial Numbers: CWP603713S
CWP601986S
CWP600810S
CWP602954S
CWP602169S
CWP602564S
CWP602486S
CWP601838S
CWP600696S
CWP602627S
CWP602315S
CWP602621S
CWP604004S
CWP603407S
CWP603894S
CWP604066S
CWP602233S
CWP603772S
CWP603201S

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 →

Severe
Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
Critical
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Severe
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28

Same hazard · device malfunction