Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
This recall has been terminated (originally issued February 3, 2014).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- January 20, 2014
- Posted
- February 3, 2014
- Terminated
- March 24, 2014
- Recall Number
- Z-0918-2014
- Quantity
- 422
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
lot 59617777 and 59658495.
Root 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.