FDA Medical Device Recalls (openFDA)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): 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.
- Recall number
- Z-1650-2021
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- 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.
- Status
- Terminated
- Initiated
- 2021-04-07
- Posted
- not on file
- Terminated
- 2024-08-23
- Reason
- The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
- Root cause
- Process control
- Action
- 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.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of North Carolina.
- Lot, serial or model codes
- Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
- 510(k) numbers
- not on file
- PMA numbers
- ["P010031S674"]
- Product code
- NIK
- Firm FEI
- 2182208
- Firm city
- Mounds View
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28