Recall Z-0918-2014
Edwards Lifesciences, LLC · initiated January 20, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Codes / lots: lot 59617777 and 59658495.
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0918-2014
- Initiated
- January 20, 2014
- Posted by FDA
- February 3, 2014
- Terminated
- March 24, 2014
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
- Quantity
- 422
- Distribution
- Nationwide Distribution
- Recalling firm
- Edwards Lifesciences, LLC, Draper, UT