Expo 5F Selective Angiographic Catheters recall
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
Why was Expo 5F Selective Angiographic Catheters recalled?
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 08714729249399, Batch Numbers: 60429298, 60451469, 60459243, 60481409, 60535930, 60434211, 60454956, 60463953, 60490141, 60535931, 60436616, 60459198, 60463979, 60517312, 60536204
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 2314 catheters
- Distribution
- Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
- Recall date
- May 22, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)