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U.S. Department of Health and Human Services

Class 2 Device Recall Crimper

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 Class 2 Recall
Crimper
see related information
Date Posted February 03, 2014
Recall Status1 Terminated on March 24, 2014
Recall Number Z-0918-2014
Recall Event ID 67362
Premarket Approval
PMA Number
P100041
Product Classification Aortic Valve, Prosthesis, Percutaneously Delivered - Product Code NPT
Product Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Code Information lot 59617777 and 59658495.
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper, Utah 84020-9414
For Additional Information Contact Robert Becker
801-565-5203
Manufacturer Reason
for Recall
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 Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Edwards Lifesciences issued an Urgent Product Notice to all customers. Letters were sent via Fed Ex on 01/20/14. The letter outlines steps to be taken to enable a valve to fit into the open orifice, and allow the valve to be crimped according to normal instructions. Customers were instructed to forward the Urgent Product Notification letter to necessary personnel within their organization. Customers were also instructed to acknowledge they have reviewed and understand the notification letter by signing and dating the form included with the letter. Customers with questions were instructed to contact their Edwards Clinical Specialist.
Quantity in Commerce 422
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NPT and Applicant = EDWARDS LIFESCIENCES, LLC.
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