Z-1480-2022Class II

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Name: Z-1480-2022 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2020-11-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-11-05 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) on 2020-11-05. FDA classified it as Class II and gives the reason as "Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1480-2022
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-05
Posted: 2022-07-28
Recalling firm: Medtronic, Inc.
Product: Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Root cause tag: manufacturing process
FDA 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 in commerce: 3 units
Distribution: US Nationwide distribution in the states of Indiana and CA.
Product codes and lots: GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1480-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1480-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-28

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)