Medtronic COBALT HF QUAD CRT-D MRI SureScan Recall for Potential Loss of Function
Medtronic is recalling two specific COBALT HF QUAD CRT-D MRI SureScan devices due to a rare component 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. The hazard involves the potential loss of function of an implantable cardioverter defibrillator, which is a significant risk to patient safety and aligns with the 'Severe' criteria for significant injury risk or structural defects in medical devices.
Plain-English summary
Medtronic Inc. is recalling two units of the COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ. This is an MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR). The affected devices have serial numbers RTK602501S and RTK602506S.
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 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 or Medtronic for further instructions.
The recalled product
- Product
- Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
- 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: RTK602501S
- RTK602506S
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.
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