Cobalt Implantable Defibrillators May Deliver Reduced Shock Energy
Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.
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: The FDA classified this as a Class I recall, which requires a minimum severity score of 4. Although no injuries or deaths have been reported, the potential for reduced shock energy output could impair life-critical defibrillation therapy function.
Plain-English summary
Medtronic Inc. is recalling certain Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected Cobalt models include Cobalt HF CRT-D (models DTPB2D4, DTPB2D1) and Cobalt HF Quad CRT-D (models DTPB2QQ, DTPB2Q1). Approximately 1,408 units of these devices have been distributed worldwide.
The recalled devices may deliver reduced shock energy during high-voltage therapy, delivering approximately 79% of the programmed energy instead of the full amount. This reduced energy delivery could affect the devices' ability to deliver appropriate defibrillation therapy.
Patients with these implanted devices should consult their healthcare provider or Medtronic regarding whether their specific device is affected, based on the device model number and serial number.
The FDA has classified this as a Class I recall.
The recalled product
- Product
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- 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.
Lot numbers (20)
- a. Model Numbers: DTPB2D4: GTIN 00763000178215
- Serial Numbers: RTO600239S
- RTO600280S
- RTO600409S
- RTO600468S
- RTO600544S
- RTO600701S
- RTO600712S
- RTO601012S
- RTO601031S
- RTO601113S
- RTO601150S
- RTO601156S
- RTO601205S
- RTO601223S
- RTO601549S
- RTO601612S
- RTO601620S
- RTO601784S
- RTO601793S
Distribution
Distribution scope not specified by the agency.
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