Health product recall

Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery System

Brand(s)
Last updated

Summary

Product
Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery System - 80cm Shaft 82180267 82206059 82208532 82191527 82193089 82184806 82191321 PG2990BPS PG3990BPS
Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery System - 135cm Shaft 82185924 82208528 82208524 82211296 PG2990BPX PG3990BPX

Issue

Cordis has become aware of an increased trend for stent dislodgement related to two specific sizes of the Palmaz genesis® transhepatic biliary stent on Opta® pro .035" delivery system that were produced during a particular timeframe.

Recall start date: May 20, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

Cordis Cashel

Cahir Road, Cashel, Tipperary, Ireland,

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64239

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