Recall Z-2479-2023 ยท NKM Mitral Valve Repair Devices
Edwards Lifesciences, LLC
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
| Date | Aug 29, 2023 (initiated Jul 27, 2023) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation. |
| Root cause | Process change control |
| Action | On 7/27/23, recall notices were sent to customers and distributors who were asked to do the following: 1) Stop using and work with your firm representative to return affected devices. 2) Share this notice with the appropriate clinical staff at your site. 3) Complete and return the customer acknowledgement form. 4) Distributors: Notify your customers by sending this customer notification to any of your customers who have purchased the impacted devices. |
| Quantity | 92 |
| Distribution | International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.