FDA Medical devices recall ·
CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent… recall
- Recall number
- Z-0302-2027
- 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
- 11238 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CareLink SmartSync Programmer, Model 24970A, 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 00763000044688, Serial Number SPM001252A; GTIN 00763000044688, Serial Number SPM001274A; GTIN 00763000044688, Serial Number SPM001303A; GTIN 00763000044688, Serial Number SPM001309A; GTIN 00763000044688, Serial Number SPM001317A; GTIN 00763000044688, Serial Number SPM001321A; GTIN 00763000044688, Serial Number SPM001323A; GTIN 00763000044688, Serial Number SPM001332A; GTIN 00763000044688, Serial Number SPM001375A; GTIN 00763000044688, Serial Number SPM001505A; GTIN 00763000044688, Serial Number SPM001554A; GTIN 00763000044688, Serial Number SPM001565A; GTIN 00763000044688, Serial Number SPM001576A; GTIN 00763000044688, Serial Number SPM001582A; GTIN 00763000044688, Serial Number SPM001585A; GTIN 00763000044688, Serial Number SPM001588A; GTIN 00763000044688, Serial Number SPM001589A; GTIN 00763000044688, Serial Number SPM001611A; GTIN 00763000044688, Serial Number SPM001619A; GTIN 00763000044688, Serial Number SPM001624A; GTIN 00763000044688, Serial Number SPM001634A; GTIN 00763000044688, Serial Number SPM001645A; GTIN 00763000044688, Serial Number SPM001657A; GTIN 00763000044688, Serial Number SPM001660A; GTIN 00763000044688, Serial Number SPM001673A; GTIN 00763000044688, Serial Number SPM001686A; GTIN 00763000044688, Serial Number SPM001687A; GTIN 00763000044688, Serial Number SPM001690A; GTIN 00763000044688, Serial Number SPM001698A; GTIN 00763000044688, Serial Number SPM001712A; GTIN 00763000044688, Serial Number SPM001713A; GTIN 00763000044688, Serial Number SPM00175
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-0302-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.