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
- PRECISE PRO RX NITINOL STENT SYSTEM - 30MM
- 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