HURRICANE RX BILIARY BALLOON DILATATION CATHETER
Brand(s)
Last updated
Summary
Product
HURRICANE RX BILIARY BALLOON DILATATION CATHETER
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| HURRICANE RX BILIARY BALLOON DILATATION CATHETER | More than 10 numbers, contact manufacturer. | M00545890 M00545900 M00545910 M00545920 M00545930 M00545940 M00545950 M00545960 |
Issue
|
Boston Scientific Corporation (BSC) is initiating a removal of specific lots/batches of Hurricane RX Biliary balloon dilatation catheters in response to an increase in complaints reported for Pinholes in the balloon. The user may notice that the balloon either rapidly loses pressure or fails to gain or maintain pressure. To date, there have been no serious patient injuries reported.
Recall date: 2021-10-21 |
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies
|
BOSTON SCIENTIFIC CORPORATION 300 BOSTON SCIENTIFIC WAY, MARLBOROUGH MASSACHUSETTS, UNITED STATES 01752 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63553
Get notified
Receive emails about new and updated recall and safety alerts.