FDA Medical Device Recalls (openFDA)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
- Recall number
- Z-1480-2022
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Product
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
- Status
- Open, Classified
- Initiated
- 2020-11-05
- Posted
- 2022-07-28
- Terminated
- not on file
- Reason
- Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
- Root cause
- Process control
- Action
- On 05-Nov-2020, Medtronic initiated retrieval activities via verbal communication to consignees who were in possession of unused, affected devices according to Medtronic records. Consignees were advised to quarantine all affected devices within their possession. In the United States, a written communication was mailed to two (2) identified consignees on 24-Nov-2020, directing the return of all unused, affected devices.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of Indiana and CA.
- Lot, serial or model codes
- GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
- 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