Sorin recalls Platinium CRT-D 1741 DF-4 defibrillators with hardware configuration issues that may cause loss of pacing and sensing, risking failure to detect life-threatening arrhythmias.
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 defibrillators that may lose their ability to detect dangerous heart rhythms due to a hardware configuration error. This could lead to a failure to deliver necessary shock therapy during a life-threatening event.
The device's hardware configuration may cause it to overconsume power, which leads to loss of pacing and sensing functions. Without these functions, the device cannot identify when a life-threatening arrhythmia occurs and requires a shock therapy.
People with a Sorin Platinium CRT-D 1741 DF-4 defibrillator (model TDF037U) implanted in their heart. Those who have the listed serial numbers are most at risk.
Check if your defibrillator has the model number TDF037U and the serial numbers listed: 637DC0D0, 637DC13F, 625DC128, 622DC17A, 620DC034, 627DC0E0, 619DC101, 620DC07F, 622DC02C, 619DC0E1.
Verify your defibrillator's model number is TDF037U and matches one of the listed serial numbers.
The device's hardware configuration may cause it to overconsume power, leading to loss of pacing and sensing functions and potentially failing to detect life-threatening arrhythmias.
Check if your device has the model TDF037U and one of the listed serial numbers. If so, contact Sorin for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Sorin to request your refund or repair — edit it as you like.
Subject: Recall Z-2825-2018 — Sorin Sorin Hello, I own a Sorin that is covered by recall Z-2825-2018 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.
