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 for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.
FDA Recall Z-2735-2018 · Posted None
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2017-12-11
Date Terminated2019-11-04
Product Quantity31,005
Reason for Recall
Potential polymer material degradation.
Firm 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 [email protected].
Root Cause
Process change control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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