Health product recall

PRECISE PRO RX NITINOL STENT SYSTEM (2021-02-16)

Starting date:
February 16, 2021
Posting date:
March 4, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75067

Last updated: 2021-03-04

Affected Products

  1. PRECISE PRO RX NITINOL STENT SYSTEM - 30MM
  2. PRECISE PRO RX NITINOL STENT SYSTEM - 40MM

Reason

This voluntary recall is being conducted because Cordis recently confirmed complaints for distal tip separation from the wire lumen that may be the result of inadequate joint adhesion. Cordis has isolated the issue to particular lots of product made between October 2019 and August 2020.

Affected products

A. PRECISE PRO RX NITINOL STENT SYSTEM - 30MM

Lot or serial number
  • 17919722
  • 17922173
  • 17923714
  • 17926319
  • 17926323
  • 17927596
  • 17928284
  • 17932847
Model or catalog number
  • PC0630XCE
  • PC0730XCE
  • PC0930XCE
Companies
Manufacturer
Cordis Corporation
14201 NW 60TH AVE.
MIAMI LAKES
33014
Florida
UNITED STATES

B. PRECISE PRO RX NITINOL STENT SYSTEM -40MM

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • PC0540XCE
  • PC0640XCE
  • PC0740XCE
  • PC0840XCE
  • PC0940XCE
Companies
Manufacturer
Cordis Corporation
14201 NW 60TH AVE.
MIAMI LAKES
33014
Florida
UNITED STATES