Boston Scientific Cardiac Catheters Recalled for Material Delamination
Boston Scientific is recalling certain Expo 5F cardiac catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during procedures. The recall affects 290 catheters 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: FDA Class I classification mandates a minimum severity of 4 per the rubric. The delamination and material detachment directly impair the catheter's critical function—guidewire advancement—which is essential during cardiac catheterization. Although the source text does not report specific illnesses or injuries, the Class I designation indicates a serious potential hazard to patient health.
Plain-English summary
Boston Scientific Corporation is recalling certain Expo 5F Selective Angiographic Catheters (MODEL 5F EXPO FR6, 5-pack) due to manufacturing defects affecting the catheter's inner lining. The defect involves delamination and detachment of the polyurethane layer within the device.
The defect may prevent physicians from advancing the guidewire through the catheter's lumen during angiographic procedures. This malfunction could compromise the success of cardiac catheterization procedures and potentially result in serious patient harm if it occurs during critical intervention.
The recall affects approximately 290 catheters with batch numbers 60493978 and 60530035, distributed worldwide including the United States, US Territories, EMEA region, Canada, Latin America, and Asia Pacific countries. The affected product is identified by UDI/DI 08714729187714.
Physicians and healthcare facilities should immediately discontinue use of affected catheters and contact Boston Scientific. Patients who underwent procedures using these catheters should consult their physicians regarding any symptoms or concerns related to their procedures.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 290
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 (3)
- UDI/DI 08714729187714
- Batch Numbers: 60493978
- 60530035
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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