Z-1650-2021Class II

Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy...

Name: Z-1650-2021 Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2021-04-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-04-07 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable... on 2021-04-07. FDA classified it as Class II and gives the reason as "The device may contain a manufacturing defect of a missing resistance spot weld (RSW)". 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-1650-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-07
Posted: 2021-05-20
Terminated: 2024-08-23
Recalling firm: Medtronic, Inc.
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.
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Root cause tag: manufacturing process
FDA 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 in commerce: 2 units
Distribution: US Nationwide distribution in the state of North Carolina.
Product codes and lots: Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1650-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1650-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-26	2021-05-20

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)