Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model TDF037U, UDI GTIN 08031527015484 Serial Numbers: 637DC0D0, 637DC13F, 625DC128, 622DC17A, 620DC034, 627DC0E0, 619DC101, 620DC07F, 622DC02C, 619DC0E1
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sorin CRM SAS
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Product Codes/Lot Numbers:
Model TDF037U, UDI GTIN 08031527015484 Serial Numbers: 637DC0D0, 637DC13F, 625DC128, 622DC17A, 620DC034, 627DC0E0, 619DC101, 620DC07F, 622DC02C, 619DC0E1
Distribution:
Distributed in: US, NJ, AZ, MS, OK, LA, PA, FL, MI, IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2825-2018
Related Recalls
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Sorin CRM SAS
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.