Medtronic CareLink Encore 29901 Programmer — Class II medical device recall Z-1525-2020
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2020-03-25, distributed nationwide. Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access
| Recall number | Z-1525-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2020-01-30 |
| Classified | 2020-03-19 |
| Reported by FDA | 2020-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, AW, BB, BD, BE, BG, BM, BO, BR, BS, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 5,540 devices |
| UPC / GTIN / UDI-DI | 00613994909558, 00643169121973, 00643169166981, 00643169166998, 00643169167025, 00643169167070, 00643169167087, 00643169167094, 00643169225732, 00643169369030, 00643169369047, 00643169763548, 00643169763555, 00643169763562, 00643169763593, 00643169763609, 00643169763623, 00643169955813, 00763000050986, 00763000156640, 00763000156657, 00763000156664, 00763000156671, 00763000156701 |
| Lot numbers | 00643169, 763593 |
| Model numbers | 29901, 29901A |
Product
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Reason for recall
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
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-1525-2020. 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.