PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS

FDA device recall Z-2479-2023 · posted 2023-08-29 · Open, Classified

Recall details

Recalling firm

Edwards Lifesciences, LLC

Reason for recall

Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.

Action taken

On 7/27/23, recall notices were sent to customers and distributors who were asked to do the following: 1) Stop using and work with your firm representative to return affected devices. 2) Share this notice with the appropriate clinical staff at your site. 3) Complete and return the customer acknowledgement form. 4) Distributors: Notify your customers by sending this customer notification to any of your customers who have purchased the impacted devices.

Root cause

Process change control

Status

Open, Classified

Product code

NKM

Quantity affected

92

Distribution

International distribution to the countries of Austria, Belgium, Switzerland, Germany, Cyprus, Israel, UK, Greece, Ireland, Italy, Luxembourg, Poland.

Date initiated

2023-07-27

Date posted

2023-08-29

Location

Irvine, CA