Medtronic InSync III — Class II medical device recall Z-0342-2016
Terminated recall by Medtronic Inc., reported 2015-12-09, distributed nationwide. Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performanc
| Recall number | Z-0342-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Saint Paul, MN, United States |
| Recall initiated | 2015-11-09 |
| Classified | 2015-11-27 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2016-08-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BM, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TN, TR, TT, UA, UY, VE, VN, ZA |
| Quantity | 96,787 |
| Serial numbers | PKF100010H, PKF100011H, PKF100012H, PKF100013H, PKF100014H, PKF100015H, PKF100016H, PKF100018H, PKF100019H, PKF100020H, PKF100021H, PKF100022H, PKF100023H, PKF100024H, PKF100025H, PKF100026H, PKF100027H, PKF100028H, PKF100029H, PKF100030H, PKF100031H, PKF100032H, PKF100033H, PKF100034H, PKF100035H and 475 more |
| Model numbers | 8042, 8042B, 8042U |
Product
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Reason for recall
Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
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-0342-2016. 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.