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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