Expo 5F Catheters Recalled for Guidewire Advancement Failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The issue affects 440 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: This device is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric. Although no injuries or deaths are reported, the inability to advance a guidewire through a cardiac catheter represents a critical device malfunction that could impact patient care during an invasive procedure.
Plain-English summary
Boston Scientific Corporation is recalling certain batches of Expo 5F Selective Angiographic Catheters, which are used during cardiac diagnostic and interventional procedures. The affected product is the 5F EXPO CLS2.5 model (5-pack), Reference Number H74908526572A2, Batch Number 60468842.
The recall was initiated due to complaints about an inability to advance the guidewire through the device's lumen in certain batches. Investigation revealed polyurethane layer delamination and, in some cases, material detachment within the catheter's inner lining. These defects can prevent proper device function during critical cardiac procedures.
Approximately 440 catheters have been distributed worldwide, including to the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific countries. The FDA has classified this as a Class I recall. Healthcare providers who have received these catheters should immediately stop using the affected batch and contact Boston Scientific for return and replacement instructions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 440
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 08714729812166
- Batch Numbers: 60468842
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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