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Terminated

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Recall Z-1342-2016 · Posted 2016-04-18

Recall StatusTerminated
Product CodeDXE
Date Initiated2016-03-22
Date Terminated2017-08-11
Product Quantity21,155 units

Reason for Recall

Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.

Firm Action

The firm,Boston Scientific, "Urgent Medical Device Recall Notice - Immediate Action Required" letter dated 3/22/2016. The letter was addressed to Material Manger / Field Action Contact. The letter described the problem and the product involved in the recall and actions to be taken. The customers were instructed to immediately cease further distribution or use of the product and complete and return the Reply Verification Tracking Form via email: [email protected] or fax to: BSC Field Action Center at 1-866-213-1806. Distributors should notify their customers of the recall and inform them that this recall is to the hospital level. For questions regarding this communication, please contact your local Boston Scientific Sales Representative or the Boston Scientific Field Action Center at 763-494-1133 or email: [email protected].

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - US (nationwide) including DC & VI except DE, ID, SD, and WY and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Cyprus, Ecuador, France, Germany, Great Britain, Hungary, Italy, Japan, Jordan, Korea, Malaysia, Mauritius, Mexico, Netherlands, Philippines, Portugal, South Africa, Spain, Sweden, Thailand, Trinidad, Tobago, and Uruguay.

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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