MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices — Class II medical device recall Z-0796-2019
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2019-02-13, distributed in GA. The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use i
| Recall number | Z-0796-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2019-01-17 |
| Classified | 2019-02-01 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2021-02-02 |
| Distributed | GA |
| Countries outside the US | BG, HR, HU, IN, IR, JO, LB, LV, OM, PK, QA, RO, SA |
| Quantity | 33,007 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00613994909558, 00643169121973, 00643169166974, 00643169166981, 00643169166998, 00643169167001, 00643169167018, 00643169167025, 00643169167049, 00643169167063, 00643169167070, 00643169167087, 00643169167094, 00643169167100, 00643169225732, 00643169225749, 00643169225756, 00643169225763, 00643169225770, 00643169369030, 00643169369047, 00643169763401, 00643169763548, 00643169763555, 00643169763562 and 6 more |
| Serial numbers | 00643169167025, 00643169167049, 00643169167070, 00643169167087, 00643169369030, 00643169369047, 00643169763548, 00643169763555, 00643169763562, 00643169763593, 00643169763609, 00643169763623, 00643169955813, 00763000050986, 00763000156640, JVD000322P, JVD000328P, JVD000374P, JVD000378P, JVD000423P, JVD000439P, JVD000496P, JVD001018P, JVD001023P, JVD001025P and 475 more |
Product
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Reason for recall
The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0796-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.