Edwards Lifesciences, LLC: Medical Device Recall in 2014 - (Recall #: Z-0918-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 20, 2014

Date Posted: February 12, 2014

Recall Number: Z-0918-2014

Event ID: 67362

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.

Status: Terminated

Product Quantity: 422

Code Information:

lot 59617777 and 59658495.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated