Medtronic — Class II medical device recall Z-1607-2013
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2013-07-03, distributed in AL, AR, CA, FL, GA, IL, IN, KS…. Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during produ
| Recall number | Z-1607-2013 |
|---|---|
| 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 | 2013-06-07 |
| Classified | 2013-06-27 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2014-03-07 |
| Distributed | AL, AR, CA, FL, GA, IL, IN, KS, KY, LA, ME, MI, MN, MO, NE, NY, OH, OK, PA, PR, SC, TN, TX, VA, WI |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, DE, DK, EC, EG, ES, FI, FR, GB, HU, IE, IT, JP, LB, LU, LV, NL, NO, PL, SE, SG, TN, TW, UY, ZA |
| Reason classes | device malfunction |
| Serial numbers | PVX610233S, PVX610234S, PVX610253S, PVX610258S, PVX610296S, PVX610302S, PVX610308S, PVX610311S, PVX610312S, PVX610313S, PVX610314S, PVX610315S, PVX610317S, PVX610318S, PVX610319S, PVX610320S, PVX610321S, PVX610323S, PVX610324S, PVX610325S, PVX610326S, PVX610328S, PVX610329S, PVX610331S, PVX610332S and 475 more |
| Model numbers | C2TR01, C3TR01, C4TR01 |
Product
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Reason for recall
Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi
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-1607-2013. 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.