Z-2168-2025Class II

Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1...

Name: Z-2168-2025 Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1...
Creator: Medtronic, Inc.
Published: 2025-06-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-06-18 / Open, Classified / root cause: software

FDA source

Medtronic, Inc. began a recall of Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number... on 2025-06-18. FDA classified it as Class II and gives the reason as "In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's...". 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-2168-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-18
Posted: 2025-07-23
Recalling firm: Medtronic, Inc.
Product: Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
Product code: NVZ Pulse Generator, Permanent, Implantable
Reason for recall: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Root cause tag: software
FDA root cause: Software design
Action: An URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter dated 6/18/25 was sent to customers. Customer Actions: "Update SmartSync (to version 4.2.3 or higher). Refer to release notes provided by your local Medtronicrepresentative for update instructions. If needed, Medtronic representatives are available to work with you toinstall or update the SmartSync application(s) on your tablet. See Appendix for instructions on how to verify thesoftware update is complete. "Sign and return the enclosed confirmation form and share this notice with those who need to be aware withinyour organization or with any organization where SmartSync may be in use. Questions regarding this informationshould be directed to the local Medtronic Representative or Medtronic Programmer Technical Services at 800-638-1991, Option 1.
Quantity in commerce: 22091 total devices
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 1. Software Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; 2. Software Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; 3. Software Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; 4. Software Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; 5. Software Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; 6. Software Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; 7. Software Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; 8. Software Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2; 9. Software Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2; 10. Software Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2; 11. Software Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2168-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2168-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-23
Z-2169-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-23

Product code NVZ

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)