Expo Angiographic Catheters
Brand(s)
Last updated
Summary
Product
Expo Angiographic Catheters
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Expo Angiographic Catheters-Femoral Left Family | More than 10 numbers, contact manufacturer. | H74908526212 H74908526242 H74908526252 H749085262202 H74908526232 H74908526222 |
| Expo Angiographic Catheters-Multipack Family | More than 10 numbers, contact manufacturer. | H749085263012 |
| Expo Angiographic Catheters-Williams Family | More than 10 numbers, contact manufacturer. | H74908526512 H74908526502 |
| Expo Amgiographic Catheter-Amplatz Left Family | More than 10 numbers, contact manufacturer. | H74908526982 H74908526842 H74908526962 H74908526862 H74908526892 |
| Expo Angiographic Catheters-Intermal Mammary Family | More than 10 numbers, contact manufacturer. | H749085262022 H749085262402 H749085262012 |
| Expo Angiographic Catheters-Left/Right Coronary Bypass Family | More than 10 numbers, contact manufacturer. | H749085261952 H749085261902 |
| Expo Angiographic Catheters-Femoral Right Family | More than 10 numbers, contact manufacturer. | H74908526022 H749085262252 H74908526012 H74908526032 |
Issue
Boston Scientific initiated a removal of certain batches of Expo 5F angiographic catheters due to an increase in complaints related to an inability to advance the guidewire through the lumen of the device. Our internal investigation has revealed that there is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Recall start date: March 21, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
| Boston Scientific Corporation |
| 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75327
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