The Recall Desk
SevereFDA (Devices)·Z-1486-2022·Announced 2022-08-17

Medtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect

Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.

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: This is an FDA Class I medical device recall, which by regulatory definition indicates a serious risk to health or safety. The Class I designation establishes the minimum severity threshold regardless of reported injuries. The potential for reduced therapy effectiveness in life-critical devices warrants the Severe classification.

Plain-English summary

Medtronic Inc. has issued a worldwide recall of certain Cobalt implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The recalled models are Cobalt XT HF CRT-D (Models DTPA2D4, DTPA2D1) and Cobalt XT HF Quad CRT-D (Models DTPA2QQ, DTPA2Q1). A total of 8,429 units have been identified as affected by this recall.

The devices have a potential defect that could result in reduced shock energy during high-voltage (HV) therapy, with affected devices potentially delivering approximately 79% of the programmed energy. This reduced energy output may impact the device's ability to successfully terminate life-threatening cardiac arrhythmias.

Patients implanted with affected devices are identified by specific serial numbers listed in the FDA recall notice. Healthcare providers should verify whether a patient's device is included in the recall by checking the device's serial number and model number. Patients with affected devices should consult with their implanting physician regarding appropriate follow-up and potential management options.

The recalled product

Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardioverter Defibrillator / CRT-D
Hazard
Affected units
8,429

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)

  • a. Model Numbers: DTPA2D4: GTIN 00763000178130
  • Serial Numbers: RTG600136S
  • RTG600270S
  • RTG601323S
  • RTG601338S
  • RTG601367S
  • RTG601433S
  • RTG601484S
  • RTG601489S
  • RTG601575S
  • RTG601583S
  • RTG601595S
  • RTG601632S
  • RTG601643S
  • RTG601653S
  • RTG601657S
  • RTG601669S
  • RTG601775S
  • RTG601790S
  • RTG601802S

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

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

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Same hazard · reduced shock energy

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