—#125336

Product

Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.

FDA product code: NPT — Aortic Valve, Prosthesis, Percutaneously Delivered
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P100041
Affected lot / code info: lot 59617777 and 59658495.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2014-01-20
Posted by FDA: 2014-02-03
Terminated: 2014-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.