Reported Aug 22, 2018 · Terminated
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy…
Sorin CRM SAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sorin CRM SAS · Cvk · Clamart Cedex · N/A
Is this the product you have?
- Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
- Lot codes and dates
- Model TDF037U
- UDI GTIN 08031527015484 Serial Numbers
637DC0D0637DC13F625DC128622DC17A620DC034627DC0E0619DC101620DC07F622DC02C619DC0E1
- Amount recalled
- 10
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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