Recalls / —
—#150395
Product
Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
- FDA product code
- DQY — Catheter, Percutaneous
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K010853, K980453
- Affected lot / code info
- Lot s 18771332, 18771915; Expiration 12/31/18. Lot s18903165, 18928715; Expiration 01/31/2019.
Why it was recalled
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 (FDA determination)
Employee error
Action the firm took
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.
Recalling firm
- Firm
- Stryker Neurovascular
- Address
- 47900 Bayside Pkwy, Fremont, California 94538-6515
Distribution
- Distribution pattern
- 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 SLOVAKIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND THAILAND TUNISIA TURKEY UK URUGUAY VIETNAM.
Timeline
- Recall initiated
- 2016-10-05
- Posted by FDA
- 2016-11-02
- Terminated
- 2017-03-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #150395. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.