Cobalt HF Quad MRI SureScan Implantable Cardioverter recall
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are…
Why was Cobalt HF Quad MRI SureScan Implantable Cardioverter recalled?
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
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?
Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
- Product
- Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are…
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of North Carolina.
- Recall date
- May 26, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)