Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1 recall
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan…
Why was Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1 recalled?
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: RTP601047S, RTP601055S
- Product
- Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan…
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 2 units
- Distribution
- Distribution to US states of GA, PA, NJ, and France
- Recall date
- February 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)