FDA Medical devices recall ·
CareLink SmartSync, RF Head Patient Connector, Model 24967… recall
- Recall number
- Z-0303-2027
- Date
- (initiated September 24, 2026)
- Company / brand
- Medtronic, Inc.
8200 Coral Sea St Ne, Mounds View, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11741 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
Why was it recalled?
Software problem has the potential for an inaccurate displayed longevity estimate.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 00763000060435, Serial Number RFA01746
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0303-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.