Edwards Lifesciences, LLC Recall: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System
Edwards Lifesciences, LLC Recall: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Edwards Lifesciences, LLC; Product: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:006
| Recalling firm | Edwards Lifesciences, LLC |
|---|---|
| Product | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260 |
| Reason for recall | 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 |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| 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 |
| Recall initiated | 20190709 |
| Recall number | Z-2227-2019 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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