Agency classClass IOur severity:Severe FDA (Devices)·Z-1722-2023·Announced 2023-06-28

Implantable cardioverter defibrillators recalled for potential therapy delivery failure

Medtronic implantable cardioverter defibrillators (ICDs) with a specific glassed feedthrough are recalled due to a rare potential for reduced or no energy output during high voltage therapy.

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: This is an FDA Class I recall. According to the severity rubric, FDA Class I classification requires a minimum severity score of 4 (Severe). Although no illnesses or injuries have been reported, the device is life-critical and failure to deliver therapy poses inherent patient safety risk.

Plain-English summary

Medtronic, Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model Number DDPA2D1G COBALT XT DR MRI DF1 GOLD. The recall involves 3 units with lot serial numbers RSL602260S, RSL602263S, and RSL602265S. The affected devices have been distributed nationwide in the United States and worldwide.

The recalled devices were manufactured with a specific glassed feedthrough component that creates a rare potential for reduced or no energy output during high voltage (HV) therapy, typically at levels between 0 and 12 joules. This defect could prevent the device from delivering the necessary therapeutic shock needed to restore normal heart rhythm during a life-threatening arrhythmia.

Patients with the affected implantable cardioverter defibrillators should verify the serial number of their device and contact their healthcare provider or Medtronic to determine if their device is included in this recall. No patient illnesses or injuries have been reported in association with this issue.

The recalled product

Product: ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Device
Hazard: reduced-energy-output
therapy-failure
Affected units: 3

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 (3)

GTIN 00763000615611. Lot Serial Numbers: RSL602260S
RSL602263S
RSL602265S

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 →

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