Medtronic Implantable Cardioverter Defibrillator Model DTPA2D1G Therapy Output Failure
Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator due to a rare potential for reduced or no energy output during high-voltage defibrillation 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 device is subject to an FDA Class I recall; however, no deaths or serious injuries have been reported and the hazard is described as a rare potential for device failure, preventing a Critical classification.
Plain-English summary
Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator (model DTPA2D1G). The devices are affected by a rare potential for reduced or no energy output during high-voltage therapy, typically in the 0-12 joule range.
The affected devices contain a specific glassed feedthrough component that may cause this malfunction. The recalled units have the following lot serial numbers: RTH602452S, RTH602446S, RTH602443S, RTH602454S, and RTH602442S. These devices were distributed nationwide in the United States and worldwide.
The recalled product
- Product
- CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- 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 (6)
- GTIN 00763000501044
- lot serial Numbers: RTH602452S
- RTH602446S
- RTH602443S
- RTH602454S
- RTH602442S
Distribution
Distributed nationwide across the United States.
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