Recall Z-2735-2018 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter
| Date | Dec 11, 2017 |
| Status | Terminated |
| Reason | Potential polymer material degradation. |
| Root cause | Process change control |
| Action | On December 11, 2017, Stryker Neurovascular sent notification to all their customers informing them of the recall. Included is a letter to be sent to each affected account which includes instructions to return product to Stryker and Form to be completed by customers to document products which have been consumed and products to be returned to Stryker. Return the completed form to your nominated Stryker Representative or to NVFieldActions@stryker.com. |
| Quantity | 31,005 |
| Distribution | Worldwide - US Nationwide Distribution - AL, FL, IL, IN, KY, MA, MI, MN, MS, NC, NV, NY, OH, OR, TN, TX, UT, WA and the country CANADA |
| FDA record | Open on fda.gov |