Expo 5F cardiac catheters recalled for material delamination
Boston Scientific Corporation recalls Expo 5F cardiac catheters due to polyurethane layer delamination and inner lining detachment that prevents guidewire advancement. Affected batch 60535890 has been distributed worldwide.
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 medical device recall, which per the severity rubric never scores below 4 (Severe). The defect prevents guidewire advancement—a critical functional failure impacting patient care procedures—though no injuries or deaths have been reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling certain Expo 5F Selective Angiographic Catheters (Model 5F EXPO JIG3.5, Batch 60535890, UDI 08714729886129) due to a manufacturing defect affecting device performance.
Affected catheters experience polyurethane layer delamination and inner lining material detachment. This defect prevents guidewires from advancing through the catheter's lumen, which is essential for angiographic procedures to function properly.
Affected catheters have been distributed worldwide, including in the US, US Territories, EMEA, Canada, LATAM, and Asia Pacific regions. An increase in complaints has been reported related to the inability to advance guidewires through the affected devices.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
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 08714729886129
- Batch Numbers: 60535890
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
- SevereExpo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
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FDA (Devices) · 2024-05-22
- SevereCardiac Catheters Recalled Due to Material Delamination and Guidewire Failure
FDA (Devices) · 2024-05-22
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