CLASS II · ModerateFDA

Medtronic, Inc. recalls CareLink SmartSync

📅 Sep 24, 2026 · 📍 See notice

Recalling company: Medtronic, Inc.
Product: CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
Reason: Software problem has the potential for an inaccurate displayed longevity estimate.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: Sep 24, 2026
Reported: Nov 4, 2026
Distribution: Worldwide distribution.
Status: Ongoing
Quantity: 11741 units
Lot / codes: GTIN 00763000060435, Serial Number RFA001598A; GTIN 00763000060435, Serial Number RFA001602A; GTIN 00763000060435, Serial Number RFA001786A; GTIN 00763000060435, Serial Number RFA001826A; GTIN 00763000060435, Serial Number RFA002016A; GTIN 00763000060435, Serial Number RFA002095A; GTIN 00763000060435, Serial Number RFA002591A; GTIN 00763000060435, Serial Number RFA003113A; GTIN 00763000060435, Serial Number RFA003146A; GTIN 00763000060435, Serial Number RFA003306A; GTIN 00763000060435, Serial Number RFA005031A; GTIN 00763000060435, Serial Number RFA005097A; GTIN 00763000060435, Serial Number RFA005103A; GTIN 00763000060435, Serial Number RFA008830A; GTIN 00763000060435, Serial Number RFA014171A; GTIN 00763000060435, Serial Number RFA014218A; GTIN 00763000060435, Serial Number RFA014252A; GTIN 00763000060435, Serial Number RFA014258A; GTIN 00763000060435, Serial Number RFA014278A; GTIN 00763000060435, Serial Number RFA014286A; GTIN 00763000060435, Serial Number RFA014342A; GTIN 00763000060435, Serial Number RFA014609A; GTIN 00763000060435, Serial Number RFA014653A; GTIN 00763000060435, Serial Number RFA014885A; GTIN 00763000060435, Serial Number RFA014952A; GTIN 00763000060435, Serial Number RFA014996A; GTIN 00763000060435, Serial Number RFA015015A; GTIN 00763000060435, Serial Number RFA016648A; GTIN 00763000060435, Serial Number RFA016815A; GTIN 00763000060435, Serial Number RFA016817A; GTIN 00763000060435, Serial Number RFA017064A; GTIN 0076300
Company location: Mounds View, MN
Recall type: Voluntary: Firm initiated
Recall number: Z-0303-2027
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0303-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.