FDA Device recall Z-2824-2018
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator by Sorin Crm Sas, citing hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrill….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2824-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-09 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Crm Sas |
| Distribution | AZ, FL, IL, LA, MI, MS, NJ, OK, PA |
Product
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Reason
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.
Identifiers
| code_info | Model TDF033U, UDI GTIN 08031527015538 Serial Numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624D…Model TDF033U, UDI GTIN 08031527015538 Serial Numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2824-2018%22
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