Implantable Cardiac Devices Risk Therapy Failure From Feedthrough Defect
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a defective feedthrough component. The FDA classified this as a Class I recall affecting 2,884 devices.
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: The FDA classified this as a Class I recall, which per the rubric establishes a minimum score of 4 (Severe). The hazard involves potential complete or partial failure of a critical life-saving implantable cardiac device during high-voltage emergency therapy, though the defect is rare and no illnesses have been reported.
Plain-English summary
Medtronic Inc. is recalling 2,884 units of the CRTD COBALT HF MRI IS1 DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model Number DTPB2D1. These are implantable devices used to monitor and treat abnormal heart rhythms, distributed nationwide and worldwide.
A specific glassed feedthrough component used in manufacturing these devices can cause reduced or no-energy output during high-voltage (HV) therapy, typically when delivering 0-12 joules. Although described as a rare potential defect, it could prevent the device from delivering critical emergency defibrillation therapy when medically necessary.
The affected devices can be identified by GTIN code 00763000178222 or 00763000178246, along with specific lot serial numbers listed in the recall notification. Patients and healthcare providers should consult the complete lot number list to determine if a particular device is included in this recall and discuss any necessary monitoring or management steps with their cardiologist.
The recalled product
- Product
- CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; 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 (20)
- GTIN 00763000178222
- Lot Serial numbers: RTP600502S
- RTP602448S
- RTP600549S
- RTP600551S
- RTP600553S
- RTP600554S
- RTP600555S
- RTP601566S
- RTP601569S
- RTP602731S
- RTP602733S
- RTP601785S
- RTP601786S
- RTP601825S
- RTP601826S
- RTP601620S
- RTP602203S
- RTP602327S
- RTP600744S
Distribution
Distributed nationwide across the United States.
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