HURRICANE RX BILIARY BALLOON DILATATION CATHETER (2020-09-16)
- Starting date:
- September 16, 2020
- Posting date:
- October 2, 2020
- 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-74047
Last updated: 2020-10-01
Affected Products
HURRICANE RX BILIARY BALLOON DILATATION CATHETER
Reason
Boston Scientific Corporation (BSC) initiated a removal of specific lots/batches of Hurricane RX Biliary Balloon Dilatation Catheters in response to an increase in complaints of the RX tunnel component (blacksheath) detaching from the catheter shaft. Investigation has shown this is due to a lower bond strength of the tunnel component which may lead to detachment.
Affected products
HURRICANE RX BILIARY BALLOON DILATATION CATHETER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- M00545890
- M00545900
- M00545910
- M00545920
- M00545930
- M00545940
- M00545950
- M00545960
Companies
- Manufacturer
-
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough
01752
Massachusetts
UNITED STATES