Implantable cardioverter defibrillators recalled for potential therapy delivery failure
Medtronic implantable cardioverter defibrillators (ICDs) with a specific glassed feedthrough are recalled due to a rare potential for reduced or no energy output during high voltage therapy.
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 recall. According to the severity rubric, FDA Class I classification requires a minimum severity score of 4 (Severe). Although no illnesses or injuries have been reported, the device is life-critical and failure to deliver therapy poses inherent patient safety risk.
Plain-English summary
Medtronic, Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model Number DDPA2D1G COBALT XT DR MRI DF1 GOLD. The recall involves 3 units with lot serial numbers RSL602260S, RSL602263S, and RSL602265S. The affected devices have been distributed nationwide in the United States and worldwide.
The recalled devices were manufactured with a specific glassed feedthrough component that creates a rare potential for reduced or no energy output during high voltage (HV) therapy, typically at levels between 0 and 12 joules. This defect could prevent the device from delivering the necessary therapeutic shock needed to restore normal heart rhythm during a life-threatening arrhythmia.
Patients with the affected implantable cardioverter defibrillators should verify the serial number of their device and contact their healthcare provider or Medtronic to determine if their device is included in this recall. No patient illnesses or injuries have been reported in association with this issue.
The recalled product
- Product
- ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; 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 (3)
- GTIN 00763000615611. Lot Serial Numbers: RSL602260S
- RSL602263S
- RSL602265S
Distribution
Distributed nationwide across the United States.
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