Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF
FDA device recall Z-0340-2017 · posted 2016-11-02 · Terminated
Recall details
- Recalling firm
- Stryker Neurovascular
- Reason for recall
- 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.
- Action taken
- 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 510-413-2106.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 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 I
- Date initiated
- 2016-10-05
- Date posted
- 2016-11-02
- Date terminated
- 2017-03-23
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GUIDER SOFTIP GUIDING CATHETER XF 5F (K010853) | Boston Scientific, Target | 2001-04-18 |
| SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K980453) | Boston Scientific Scimed, Inc. | 1998-08-11 |