Medtronic Implantable Defibrillators May Fail Therapy Energy Delivery
Medtronic recalls 3 COBALT XT implantable defibrillators that may deliver reduced or no energy during therapy. A defect in the device feedthrough could prevent effective treatment of abnormal heart rhythms.
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: FDA Class I classification indicates the potential for serious harm. Although no illnesses or injuries are explicitly reported, the risk of therapy failure in an implantable defibrillator during a cardiac emergency represents a life-threatening hazard.
Plain-English summary
Medtronic has recalled the CRTD DTPA2D1PX COBALT XT HF QUAD OUS implantable cardioverter defibrillator (ICD/CRT-D). This recall affects 3 units with lot serial numbers RTH601150S, RTH601151S, and RTH603584S. The devices were distributed nationwide and worldwide.
The recalled defibrillators contain a specific type of feedthrough component that may cause a rare potential for reduced or no-energy output during high voltage therapy, typically delivered at 0-12 joules. If energy output is reduced or absent, the device may not effectively treat abnormal heart rhythms requiring immediate correction.
Patients who have received one of the affected devices should contact Medtronic and their healthcare provider immediately to discuss options. The FDA issued a Class I recall, the highest severity level, due to the potential for serious harm if the device fails to deliver therapy during a cardiac event.
The recalled product
- Product
- CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-failure
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 (5)
- GTIN 00763000446048
- lot serial Numbers: RTH601150S
- RTH601151S
- GTIN 00763000718732
- Lot Serial Numbers: RTH603584S
Distribution
Distributed nationwide across the United States.
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