Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Malfunction
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in eight batches affecting 4942 units. The defect prevents guidewire advancement and could compromise device function during cardiac procedures.
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: FDA Class I designation requires a minimum severity score of 4. The defect is structural and affects a critical cardiac device's core functionality; inability to advance the guidewire could prevent successful angiographic procedures. While no injuries have been reported, the potential for serious harm during cardiac interventions justifies a Severe rating.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO AR MOD, Reference H74908526892) due to a defect affecting 4942 units. The defect involves delamination of the polyurethane layer and material detachment in the catheter's inner lining, which prevents guidewire advancement through the device lumen.
Eight production batches are affected: 60443056, 60452071, 60464497, 60467054, 60475380, 60511251, 60498235, and 60533590. This issue has prompted complaints regarding device malfunction during intended use in angiographic procedures.
The recalled catheters were distributed worldwide, including to the US, US Territories, EMEA region, Canada, Latin America, and Asia Pacific countries and regions.
Healthcare providers should immediately stop using affected units and contact Boston Scientific for replacement and recall-unit disposition instructions. As of this recall notice, no injuries related to this defect have been reported.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 4,942
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 (9)
- UDI/DI 08714729007692
- Batch Numbers: 60443056
- 60452071
- 60464497
- 60467054
- 60475380
- 60511251
- 60498235
- 60533590
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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