Edwards recalls SAPIEN 3 Ultra Transcatheter Heart Valve System (20mm) due to burst balloons causing retrieval issues during procedures. Affected units have UDI:00690103201239; 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 (20mm) because burst balloons during procedures make it hard to remove the device from patients. This could lead to complications if the valve isn't properly retrieved.
Burst balloons during procedures can cause the device to become stuck in the patient's body, making it difficult to remove. This may lead to complications like prolonged surgery or additional procedures to address the issue.
Patients who received the SAPIEN 3 Ultra Transcatheter Heart Valve System (20mm) with UDI:00690103201239 during procedures are affected. Medical teams using the device for heart valve replacements are most at risk.
Check for the UDI code 00690103201239 on the device packaging or label. The product is the SAPIEN 3 Ultra Transcatheter Heart Valve System (20mm) with model number 9630TF20.
Look for the UDI code 00690103201239 on the device packaging or label to confirm if it's affected.
This recall applies to the SAPIEN 3 Ultra Transcatheter Heart Valve System (20mm) with UDI:00690103201239. If you received this specific model during a procedure, it is affected.
The official recall does not specify a remedy; check the device packaging for the UDI code 00690103201239 to confirm if it's affected.
The recall record does not mention any replacement or repair options.
We’ve drafted a message you can send Edwards to request your refund or repair — edit it as you like.
Subject: Recall Z-2224-2019 — Edwards Edwards Hello, I own a Edwards that is covered by recall Z-2224-2019 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.
