Medtronic Temporary Pacemaker — Class II medical device recall Z-1661-2014
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2014-06-04, distributed in GA, GU, PR. Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing r
| Recall number | Z-1661-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2014-04-29 |
| Classified | 2014-05-23 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2014-10-08 |
| Distributed | GA, GU, PR |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BO, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, IE, IL, IN, IR, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, ZA |
| Serial numbers | PEP001001K, PEP001001P, PEP001002K, PEP001002P, PEP001003K, PEP001003P, PEP001004K, PEP001004P, PEP001005K, PEP001005P, PEP001006K, PEP001006P, PEP001007K, PEP001007P, PEP001008K, PEP001008P, PEP001009K, PEP001009P, PEP001010K, PEP001010P, PEP001011K, PEP001011P, PEP001012K, PEP001012P, PEP001013K and 475 more |
| Model numbers | 5348, 5433A, 5433V, 5832, 5832S |
Product
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).
Reason for recall
Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.
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-1661-2014. 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.