—#186969

Product

Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.

FDA product code: NIK — Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P010031S674
Affected lot / code info: Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S

Why it was recalled

The device may contain a manufacturing defect of a missing resistance spot weld (RSW).

Root cause (FDA determination)

Process control

Action the firm took

During the week of 07-Apr-2021, Medtronic initiated retrieval activities for 1 device (1 US/0 OUS) for a consignee in possession of a potentially affected, non-implanted device according to Medtronic records. The Consignee was verbally notified that the consigned units was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The representative was made aware that a formal notification to customer regarding these immediate actions would follow once the engineering evaluations were complete. In the United States, beginning 20-Apr-2021, a formal Urgent Medical Device Recall notification was delivered via a field sales representative, to the consignee who was part of the retrieval activities initiated the week of 07-Apr-2021. This letter will also be mailed via UPS 2-day delivery. The Consignee will be asked to confirm receipt of the letter and that they have acknowledge the actions taken for the non-implanted, affected product.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: US Nationwide distribution in the state of North Carolina.

Timeline

Recall initiated: 2021-04-07
Terminated: 2024-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186969. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.