Z-0928-2021Class II

Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator...

Name: Z-0928-2021 Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2020-11-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-11-15 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless... on 2020-11-15. FDA classified it as Class II and gives the reason as "Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0928-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-15
Posted: 2021-01-26
Terminated: 2025-12-23
Recalling firm: Medtronic, Inc.
Product: Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: During the week of 15-Nov-2020, Medtronic initiated retrieval activities for 6 devices (5 US/1 OUS) for consignees in possession of potentially affected, non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product, or in the case of consigned units, the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm will follow with a letter to be disseminated on 12/04/2020 to the risk managers.
Quantity in commerce: 2 units
Distribution: Distribution to US states of GA, PA, NJ, and France
Product codes and lots: Serial Numbers: RSN600251S, RSN600656S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0928-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0926-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26
Z-0927-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26
Z-0928-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26

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)