Sorin recalls specific Platinium CRT-D 1711 DF-1 defibrillators due to potential overconsumption causing loss of pacing and sensing, risking missed arrhythmia detection.
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.
Sorin is recalling specific models of implantable cardiac defibrillators because a hardware issue could cause the device to stop working properly. This means the device might not detect dangerous heart rhythms, which could lead to serious health risks if the problem isn't fixed.
The device may overconsume power, causing it to lose the ability to sense and pace the heart. This could prevent it from detecting dangerous arrhythmias that require defibrillation shocks.
People with implanted Sorin Platinium CRT-D 1711 DF-1 defibrillators (model TDF033U) are affected. Those with the listed serial numbers are most at risk.
Check if your defibrillator has the serial numbers listed: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC.
Compare your device's serial number to the list provided in the recall notice.
Reach out to Sorin CRM SAS for guidance on next steps if your device is affected.
The recalled model is Sorin Platinium CRT-D 1711 DF-1 (model TDF033U).
Check if your device has one of the listed serial numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC.
Contact Sorin CRM SAS for guidance on next steps if your device is affected.
We’ve drafted a message you can send Sorin to request your refund or repair — edit it as you like.
Subject: Recall Z-2824-2018 — Sorin Sorin Hello, I own a Sorin that is covered by recall Z-2824-2018 from Sorin. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
