Single Chamber Temporary External Pacemaker — Class II medical device recall Z-2317-2018
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2018-07-04, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed s
| Recall number | Z-2317-2018 |
|---|---|
| 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 | 2018-06-06 |
| Classified | 2018-06-28 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2021-08-13 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AT, BD, BE, CH, CN, DE, DO, ES, FI, FR, GB, IE, IL, IN, IT, KR, LU, MY, NL, NO, NP, PL, PT, RO, SA, SE, SG, SI, TR, ZA |
| Quantity | 1,108 devices |
| Serial numbers | MDB01005EP, MDB01006EP, MDB01007EP, MDB01008EP, MDB01009EP, MDB01010EP, MDB01011EP, MDB01012EP, MDB01013EP, MDB01014EP, MDB01015EP, MDB01016EP, MDB01017EP, MDB01018EP, MDB01019EP, MDB01020GP, MDB01021GP, MDB01022GP, MDB01023GP, MDB01024GP, MDB01030IP, MDB01031IP, MDB01032IP, MDB01033IP, MDB01034IP and 475 more |
| Model numbers | 53401 |
Product
Single Chamber Temporary External Pacemaker, Model 53401
Reason for recall
A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR).
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-2317-2018. 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.