Edwards recalls SAPIEN 3 Ultra Transcatheter Heart Valve System (29mm) due to burst balloons causing difficulty retrieving the device during procedures. Affected units have UDI:00690103201260; all lots.
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
Edwards is recalling its SAPIEN 3 Ultra Transcatheter Heart Valve System (29mm) because burst balloons during procedures can make it hard to remove the device from patients. This could lead to complications if the valve gets stuck in the heart.
Burst balloons in the valve system can cause the device to become stuck in the patient's heart during procedures. This makes it difficult to remove the valve, potentially leading to complications like heart damage or prolonged surgery.
Patients who received the SAPIEN 3 Ultra Transcatheter Heart Valve System (29mm) with UDI:00690103201260 during procedures are affected. Medical teams using this specific valve system are most at risk during implantation.
Check for the UDI code 00690103201260 on the valve system packaging or device. The product is the SAPIEN 3 Ultra Transcatheter Heart Valve System (29mm) with model number 9630TF29.
Look for the UDI code 00690103201260 on the valve system packaging or device.
The recall addresses reports of burst balloons that can cause difficulty retrieving the device during procedures, potentially leading to complications.
Check for the UDI code 00690103201260 on the valve system packaging or device. The product is the SAPIEN 3 Ultra Transcatheter Heart Valve System (29mm) with model number 9630TF29.
The recall does not specify a remedy, so contact Edwards Lifesciences directly for guidance.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-2227-2019 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-2227-2019 from Edwards. 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.
