Health product recall

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