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Recall Observatory FDA recall evidence

Device product

Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

Z-2824-2018

July 09, 2018

Class II

Product summary

Firm
Sorin CRM SAS
Event
Event 80636
Status
Terminated
Classification
Class II
Quantity
16
Official record key
device-enforcement:Z-2824-2018

Official wording

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.

Code information: Model TDF033U, UDI GTIN 08031527015538 Serial Numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC

Distribution pattern: US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.