Edwards Lifesciences recalls PASCAL Precision Transcatheter Valve Repair System models 20000ISM and 20000IS due to potential resistance when releasing implants, which could cause improper rotation or additional implantation.
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.
Edwards Lifesciences is recalling two specific models of PASCAL Precision Transcatheter Valve Repair Systems because they can cause resistance when releasing the implant from the delivery system. This resistance might lead to the implant rotating incorrectly or being implanted improperly, which could affect the repair's effectiveness.
The device has a manufacturing issue that causes increased resistance when rotating the release knob to remove the implant. This extra torque could cause the implant to rotate or become improperly implanted, potentially leading to complications during the repair process.
Patients who have received the PASCAL Precision Transcatheter Valve Repair System models 20000ISM or 20000IS for mitral or tricuspid valve repairs are affected. Medical professionals using these devices during procedures are most at risk.
Check for model numbers 20000ISM or 20000IS on the device packaging or labels. The Basic-UDI Code starts with 0690103S004PAS000BC. These models were sold with specific serial numbers listed in the recall notice.
Look for model numbers 20000ISM or 20000IS on the device packaging or labels.
Reach out to Edwards Lifesciences directly for guidance on next steps if you have the recalled model.
The devices can cause resistance when releasing the implant from the delivery system, which may lead to improper rotation or additional implantation.
Check for model numbers 20000ISM or 20000IS on the device packaging or labels, and look for the Basic-UDI Code starting with 0690103S004PAS000BC.
No, the recall does not require immediate discontinuation. Patients and medical professionals should contact Edwards Lifesciences for specific guidance.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2479-2023 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-2479-2023 from Edwards Lifesciences. 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.
