FDA-Device2014-02-12Class II
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Edwards Lifesciences, LLC
Hazard
Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
Sold states
Nationwide Distribution
Affected count
422
Manufactured in
12050 Lone Peak Pkwy, Draper, UT, United States
Products
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2014Don't want to check this manually?
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