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

• 
  Reason
• 
  Affected products

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