Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indica

FDA device recall Z-1342-2016 · posted 2016-04-18 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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: BSCFieldActionCenter@bsci.com 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: BSCFieldActionCenter@bsci.com.

Root cause

Process control

Status

Terminated

Product code

DXE

Quantity affected

21,155 units

Distribution

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, German

Date initiated

2016-03-22

Date posted

2016-04-18

Date terminated

2017-08-11

Location

Maple Grove, MN

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