Recall Z-2227-2019 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
| Date | Aug 21, 2019 (initiated Jul 9, 2019) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Other |
| Action | On July 09, 2019 the firm sent an Urgent Field Safety Notice REF: FCA - 141 to consignees via FEDEx Priority Overnight. The Urgent Field Safety Notice informs consignees of the following: 1. When deploying the valve, inflate the balloon slowly and continuously throughout deployment. Hold for 3 seconds at full inflation. " The delivery system requires a prescribed volume for THV deployment and proper function (11 mL, 17 mL, 23 mL, 33 mL). 2. The following warning will also be added to the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System IFU: " Failure to use slow, controlled |
| Quantity | 1754 |
| Distribution | US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.