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Terminated

Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate the placement of interventional devices into the neurovascular system.

FDA Recall Z-0885-2011 · Posted 2011-01-07

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2009-12-18
Date Terminated2011-12-19
Product Quantity94,296 units

Reason for Recall

Complaint about product quality: degradation of polymer portion of the distal section of the catheter.

Firm Action

Boston Scientific sent an Urgent Medical Device Recall and Correction letter dated December 18, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and fill out the Customer Instructions and REPLY VERIFICATION TRACKING FORM indicating the status of the affected product and send a copy of the form by fax to 510-624-1600 or e-mail to [email protected].

Root Cause

Other

Distribution Pattern

Worldwide. US Domestic including US Federal Government, and foreign countries.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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