Cobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy

Plain-English summary

Medtronic Inc. has recalled certain Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected models include the Cobalt XT VR ICD (models DVPA2D1 and DVPA2D4) and the Cobalt XT DR ICD (models DDPA2D1 and DDPA2D4). Approximately 6,884 units have been distributed worldwide. Specific affected serial numbers are listed in the official FDA recall notice.

These devices have the potential to deliver reduced shock energy—approximately 79% of the programmed energy—during high-voltage therapy. The reduced energy output could compromise the device's ability to effectively treat dangerous heart rhythms in patients who depend on the defibrillation therapy.

Patients who have received these specific devices should contact their implanting cardiologist or Medtronic directly to determine whether their device is affected. Healthcare providers should evaluate each patient's device to assess the need for monitoring, firmware updates, or replacement. Patients should continue using their device as prescribed and should not discontinue therapy without guidance from their physician.

The recalled product

Product

Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4

Manufacturer

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

Category

Medical Device — Implantable Cardioverter Defibrillator

Hazard

• reduced-shock-energy
• 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.

Distribution

Distribution scope not specified by the agency.

Related recalls