Sorin Platinium CRT-D 1741 DF-4 — Class II medical device recall Z-2825-2018
Terminated recall by Sorin CRM SAS, reported 2018-08-22, distributed in AZ, FL, IL, LA, MI, MS, NJ, OK…. Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The d
| Recall number | Z-2825-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin CRM SAS, Clamart Cedex, France |
| Recall initiated | 2018-07-09 |
| Classified | 2018-08-15 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2024-09-06 |
| Distributed | AZ, FL, IL, LA, MI, MS, NJ, OK, PA |
| Quantity | 10 |
| UPC / GTIN / UDI-DI | 08031527015484 |
| Serial numbers | 619DC0E1, 619DC101, 620DC034, 620DC07F, 622DC02C, 622DC17A, 625DC128, 627DC0E0, 637DC0D0, 637DC13F |
| Model numbers | TDF037U |
Product
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Reason for recall
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
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-2825-2018. 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.