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Edwards Lifesciences, LLC recalls Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for
Recalled February 12, 2014 · FDA recall Z-0918-2014 · Edwards Lifesciences
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. · FDA Class II
Units
422
Sold at
Nationwide Distribution
Description
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.
Product
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →