Recall Z-0730-2021 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
| Date | Jan 9, 2021 (initiated Nov 17, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | The recalling firm issued a press release on 11/17/2020, as well as letters dated 11/17/2020 issued via overnight mail delivery to the U.S. direct account medical facilities and clinical investigators. OUS customers were also issued the letter on 11/17/2020 through various methods, including email, courier, hand-delivery, and phone. The letter was flagged "Medical Device Recall-Immediate Action Required" and said BSC was conducting a removal of the unused inventory and there was no safety issue for patients who previously received the valve. The letter explained the details surrounding the r |
| Quantity | 302 devices |
| 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 Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.