Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Check against the official notice below — it lists the full affected range.
Sorin's Platinium CRT-D 1741 DF-4 implantable cardiac defibrillator and resynchronization therapy defibrillator is subject to recall due to a hardware configuration defect. The defect may cause the device to overconsume power, which could result in loss of pacing and sensing capabilities. When these functions are lost, the device cannot detect dangerous heart rhythms that would normally trigger defibrillation shock therapy. The recalled devices were distributed across ten U.S. states including New Jersey, Arizona, Mississippi, Oklahoma, Louisiana, Pennsylvania, Florida, Michigan, and Illinois.
A total of 10 affected devices have been identified, all from Model TDF037U with specific serial numbers ranging from 619DC0E1 to 637DC13F. The recall notice does not specify what action patients or healthcare providers should take regarding these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS Quantity: 10 Lot/code info: Model TDF037U, UDI GTIN 08031527015484 Serial Numbers: 637DC0D0, 637DC13F, 625DC128, 622DC17A, 620DC034, 627DC0E0, 619DC101, 620DC07F, 622DC02C, 619DC0E1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.