Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy
Some Medtronic implantable defibrillators contain a specific feedthrough that may rarely cause reduced or no energy output during high-voltage therapy. The recall affects approximately 4,151 units distributed nationwide.
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 device recall, which indicates potential for serious adverse health consequences. Although no illnesses or deaths have been reported, the rare potential for complete therapy failure in a life-sustaining implantable device warrants a Severe rating.
Plain-English summary
Medtronic has recalled implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific feedthrough. The CRTD COBALT XT HF MRI IS1 DF1 (Model Number DTPA2D1) is among the recalled devices, with approximately 4,151 units distributed throughout the United States and worldwide.
The recalled devices may rarely produce reduced or no energy output during high-voltage (HV) therapy, typically at energy levels of 0-12 joules. This potential malfunction is related to a specific feedthrough component used in the devices' manufacturing.
Patients who have been implanted with these devices should contact their healthcare provider for further information regarding this recall.
The recalled product
- Product
- CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- 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)
- GTIN 00763000178147
- Lot Serial numbers: RTH601483S
- RTH602021S
- RTH602022S
- RTH602302S
- RTH602303S
- RTH602305S
- RTH602306S
- RTH605169S
- RTH602089S
- RTH603993S
- RTH601526S
- RTH600467S
- RTH600514S
- RTH600533S
- RTH600607S
- RTH600608S
- RTH601387S
- RTH601543S
- RTH601544S
Distribution
Distributed nationwide across the United States.
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