Recall Z-0339-2017 ยท DQY Catheter, Percutaneous
Stryker Neurovascular
Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
| Date | Nov 2, 2016 (initiated Oct 5, 2016) |
| Status | Terminated |
| Reason | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. |
| Root cause | Employee error |
| Action | Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated October 5, 2016, to all affected customers by Federal Express. Letters advised of the reason for recall and models and devices affected and requested that all affected devices in inventory be returned to Stryker. Customers were advised to circulate the Field Safety Notice internally to all interested/affected parties and to complete the attached customer response form and return the form to their nominated Stryker Representative or to NVFieldActions@stryker.com. For questions regarding this recall call 510-413-2 |
| Quantity | 1478 devices, all models and lot numbers |
| Distribution | Worldwide Distribution - US including AK, IL, OH and Internationally to: ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CZECH REPUBLIC ECUADOR EGYPT FRANCE GERMANY GREECE HUNGARY INDIA IRAN ISRAEL ITALIA JAPAN MEXICO NETHERLANDS NORWAY PERU PHILIPPINES POLAND RUSSIA SERBIA SINGAPORE SLOVAKI |
| FDA record | Open on fda.gov |