Edwards recalls SAPIEN 3 Ultra 26mm heart valve systems with burst balloons that cause difficulty retrieving the device during procedures. Affected units have UDI:00690103201253; 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 26mm heart valve systems due to burst balloons that make it hard to remove the device from patients during procedures. This could lead to complications during surgery.
Burst balloons in the valve system can cause the device to become stuck in the patient's body during surgery. This makes it difficult to remove the device, potentially leading to complications or extended procedures.
Patients undergoing heart valve replacement procedures who received the SAPIEN 3 Ultra 26mm valve system with UDI:00690103201253. Medical teams using the device during procedures are most at risk.
Check for the UDI code 00690103201253 on the valve system packaging or label. The product is the SAPIEN 3 Ultra 26mm delivery system with model number 9630TF26.
Look for the UDI code 00690103201253 on the valve system packaging or label.
The recall addresses reports of burst balloons that cause difficulty retrieving the device during procedures.
Check for the UDI code 00690103201253 on the packaging or label. If you have the code, contact Edwards Lifesciences for guidance.
The recall does not specify a fix; affected units should be checked and contacted 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-2226-2019 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-2226-2019 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.
