Expo selective angiographic cardiac catheters recalled for guidewire advancement failure
Boston Scientific is recalling Expo 5F selective angiographic catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which carries a minimum severity score of 4 per the rubric. Although no deaths, hospitalizations, or reported injuries are documented in the source text, the defect prevents proper device function during cardiac procedures. The classification remains Severe rather than Critical due to the absence of reported harm or fatalities.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO FL5 125CM, 5-pack) due to defects in the device's construction.
The catheters are experiencing polyurethane layer delamination and material detachment in the catheter's inner lining. This defect prevents healthcare providers from advancing a guidewire through the lumen of the catheter, making the device unsuitable for its intended angiographic use.
This recall affects catheters distributed worldwide, including the United States, U.S. Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Batch number 60533582 is subject to this recall.
Hospitals and healthcare facilities using these catheters should stop use immediately and contact Boston Scientific for instructions on return and replacement.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 08714729007579
- Batch Numbers: 60533582
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 48 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Same hazard · material delamination
See all →- SevereExpo 5F cardiac catheters recalled for material delamination worldwide
FDA (Devices) · 2024-05-22
- SevereExpo 5F Catheters Recalled for Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
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