Z-0779-2024Class II

Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

Name: Z-0779-2024 Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Creator: Medtronic Inc.
Published: 2023-12-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-12-07 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Inc. began a recall of Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 on 2023-12-07. FDA classified it as Class II and gives the reason as "During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the...". 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-0779-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-07
Posted: 2024-01-22
Recalling firm: Medtronic, Inc.
Product: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic hand delivered an Urgent Medical Device Recall/Retrieval notice to its sole consignee on 12/07/2023. The notice explained the issue and indicated that the device would be collected and a replacement provided.
Quantity in commerce: 1 device
Distribution: US Nationwide distribution in the state of Florida.
Product codes and lots: UDI/DI 00763000178338, Serial Number RSL604096S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0779-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0779-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-22

Product code LWS

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)