Recall Z-2452-2024 ยท PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Boston Scientific Corporation
Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
| Date | Jul 30, 2024 (initiated Jun 27, 2024) |
| Status | Open, Classified |
| Reason | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention. |
| Root cause | Process change control |
| Action | On June 27, 2024 URGENT MEDICAL DEVICE REMOVAL - IMMEDIATE ACTION REQUIRED letters were sent to consignees. Actions to be taken: This removal affects only the products listed in Attachment 1 (Affected Products). No other material numbers or lots are impacted by this removal. Further distribution or use of any remaining product affected by this removal should cease immediately. For Capio SLIM devices that were successfully used in a procedure, no action is needed. Affected worldwide regulatory authorities are being notified of this removal as required. Immediately post this information in a vis |
| Quantity | 70,890 units total |
| Distribution | Domestic: Nationwide Distribution. International: Pending |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172060 | Capio SLIM Suture Capturing Device Boston Scientific Corporation, Nov 3, 2017 |