Boston Scientific Corporation Recall: Lotus Edge Valve System, Transcatheter Aortic Valve
Boston Scientific Corporation Recall: Lotus Edge Valve System, Transcatheter Aortic Valve is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile,
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Product | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904 |
| Reason for recall | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Government distribution was also made. Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech Repu |
| Recall initiated | 20201117 |
| Recall number | Z-0728-2021 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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