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Recall Observatory FDA recall evidence

Device product

Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

Z-2825-2018

July 09, 2018

Class II

Product summary

Firm
Sorin CRM SAS
Event
Event 80636
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2825-2018

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 TDF037U, UDI GTIN 08031527015484 Serial Numbers: 637DC0D0, 637DC13F, 625DC128, 622DC17A, 620DC034, 627DC0E0, 619DC101, 620DC07F, 622DC02C, 619DC0E1

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.