Medtronic Cobalt HF CRT-D MRI SureScan Recall for Potential Loss of Function
Medtronic is recalling two specific Cobalt HF CRT-D MRI SureScan devices due to a rare failure mechanism that could cause loss of function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a failure mechanism could lead to loss of function, but the source text does not report any injuries, illnesses, or fatalities, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Medtronic Inc. is recalling two units of the Cobalt HF CRT-D MRI SureScan DTPB2D1 implantable cardioverter defibrillator with cardiac resynchronization therapy. The recall involves specific serial numbers RTP601047S and RTP601055S.
The recall is being issued because, under rare circumstances, a component in the device may be susceptible to a failure mechanism. This issue could impact device performance, including the potential loss of function.
The affected devices were distributed to the US states of Georgia, Pennsylvania, and New Jersey, as well as France. Patients with these specific serial numbers should contact their healthcare provider for further instructions.
The recalled product
- Product
- Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
- Hazard
- Affected units
- 2
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 (2)
- Serial Numbers: RTP601047S
- RTP601055S
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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