Medtronic Implantable Cardioverter Defibrillators May Deliver Reduced Energy During High Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators may deliver reduced or no energy during high-voltage therapy. Approximately 2,142 affected units have been identified.
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 medical device recall. Per FDA classification standards, Class I recalls score a minimum of 4 (Severe) as they indicate a product with serious health risks. The recalled devices may fail to deliver critical high-voltage therapy.
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTPC2QQ, due to a rare potential for reduced or no-energy output during high-voltage therapy (typically 0-12 joules). The issue is associated with a specific glassed feedthrough component found in these devices.
Approximately 2,142 units have been identified in the recall. These devices have been distributed nationwide and worldwide, including currently available units and previously implanted devices.
Patients with these devices should contact Medtronic Inc. for information and guidance regarding this recall.
The recalled product
- Product
- CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- energy-output-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 (20)
- GTIN 00763000178253
- Lot Serial Numbers: RTS600109S
- RTS600115S
- RTS600751S
- RTS600754S
- RTS600962S
- RTS600827S
- RTS600976S
- RTS600761S
- RTS600116S
- RTS600128S
- RTS600174S
- RTS600280S
- RTS600285S
- RTS600674S
- RTS600094S
- RTS600271S
- RTS600277S
- RTS600961S
- RTS600987S
Distribution
Distributed nationwide across the United States.
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