Recall Z-1017-2022 ยท DYB Introducer, Catheter
Freudenberg Medical, Llc
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
| Date | Feb 21, 2022 |
| Status | Terminated |
| Reason | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia |
| Root cause | Process control |
| Action | Boston Scientific issued letter dated Feb 2022 -Model 8782 EMPOWER" Introducer Sheath Product Retrieval and MODULAR ATP Clinical Study Temporary Enrollment Suspension. Letter states reason, health risk and action to take: 1. Immediately segregate all affected product to ensure that it will not be used. 2. Your local Field Clinical Engineer will retrieve and return affected product and assist you in completing the enclosed Reply Verification Tracking Form. 3. Do not enroll new patients into the MODULAR ATP Clinical Study until further communication from Boston Scientific is received. 4. Contin |
| Quantity | 8 units (OUS) |
| Distribution | US distribution: GA, OH Foreign distribution: Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190628 | FlexSeal Introducer Sheath with Hydrophilic Coating Freudenberg Medical Mis, Inc., May 30, 2019 |