Sorin Platinium CRT-D 1711 DF-1 recall
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Why was Sorin Platinium CRT-D 1711 DF-1 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model TDF033U, UDI GTIN 08031527015538 Serial Numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC
- Product
- Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
- Recalling firm
- Sorin CRM SAS
- Quantity
- 16
- Distribution
- US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)