Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Check against the official notice below — it lists the full affected range.
Sorin is recalling 16 Platinium CRT-D 1711 DF-1 implantable cardiac defibrillators distributed across ten states due to a hardware configuration defect. The defect may cause the device to overconsume power, resulting in loss of pacing and sensing capabilities. When these functions are lost, the device cannot detect dangerous heart rhythms that would normally trigger defibrillation therapy.
The recalled devices were distributed in New Jersey, Arizona, Mississippi, Oklahoma, Louisiana, Pennsylvania, Florida, Michigan, and Illinois. Affected consumers can identify whether they have a recalled device by checking if their device model is TDF033U and their serial number matches one of the 16 serial numbers listed in the recall notice. The recall record does not specify a remedy or recommended action for affected consumers.
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: 16 Lot/code info: Model TDF033U, UDI GTIN 08031527015538 Serial Numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.