FDA-Device2016-04-27Class I
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.
Boston Scientific Corporation
Hazard
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.
Sold states
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.
Affected count
21,155 units
Manufactured in
2 Scimed Pl, N/A, Maple Grove, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1342-2016Don't want to check this manually?
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