Z-1528-2021Class II

CareLink SmartSync Device Manager -

Name: Z-1528-2021 CareLink SmartSync Device Manager -
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2021-04-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-04-06 / Open, Classified / root cause: software

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac... on 2021-04-06. FDA classified it as Class II and gives the reason as "A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1528-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-06
Posted: 2021-05-04
Recalling firm: Medtronic, Inc.
Product: CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Root cause tag: software
FDA root cause: Software design
Action: Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2- day UPS delivery of the consignee letter. Consignees were asked to confirm receipt of the notification. Medtronic Field Representatives have been instructed to begin installation of the software update. Outside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Confirmation will be obtained per locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally. A courtesy notification will be provided to physicians with affected devices.
Quantity in commerce: 16,311 units
Distribution: Worldwide distribution.
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1528-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1525-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-05-04
Z-1526-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-05-04
Z-1527-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-05-04
Z-1528-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-05-04

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)