Z-1522-2021Class II

CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED)

Name: Z-1522-2021 CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED)
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 (24970A). used to interrogate cardiac implantable electronic devices (CIED) on 2021-04-06. FDA classified it as Class II and gives the reason as "There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time...". 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-1522-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-06
Posted: 2021-04-30
Recalling firm: Medtronic, Inc.
Product: CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Product code: OSR Pacemaker/Icd/Crt Non-Implanted Components
Reason for recall: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
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. Confirmation delivery of the consignee letter will be obtained. 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. Medtronic Field Representatives will begin installation of the software update as it is available locally. Consignees were advised that Medtronic representatives can assist in installing the software update on programmers. During device interrogation with an updated programmer at implant or the next regularly scheduled clinic visit, a patients device will automatically receive the updated software. A courtesy notification will be provided to physicians. No confirmation will be required for the courtesy notification.
Quantity in commerce: 16,311 devices
Distribution: Worldwide
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1522-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1522-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-04-30
Z-1523-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-04-30

Product code OSR

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)