HURRICANE RX BILIARY BALLOON DILATATION CATHETER
Brand(s)
Summary
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 |
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
|
BOSTON SCIENTIFIC CORPORATION 300 BOSTON SCIENTIFIC WAY, MARLBOROUGH MASSACHUSETTS, UNITED STATES 01752 |
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