Recall Z-2824-2018 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Sorin CRM SAS
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
| Date | Jul 9, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | On 07/09/2018, Urgent Field Safety Notices were mailed via certified postal service to physicians informing them about the removal of the non implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients, which includes patient follow-up one month after discharge, and then every three months until the device nears the replacement date. Follow-up should include checking for battery status and system warnings. The firm recommends that patients be enrolled in remote monitoring. Physicians were instructed to fill out Customer |
| Quantity | 16 |
| Distribution | US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.