Boston Scientific Cardiac Catheters Recalled Due to Guidewire Advancement Failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that may prevent guidewire advancement. The recall affects 15,079 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 is an FDA Class I recall, which per the rubric guidelines represents a minimum Severe classification when the agency's classification is Class I. Although no illnesses or injuries are reported in the source material, the manufacturing defect—material delamination and detachment—directly prevents the device from performing its intended angiographic function, posing a risk to patient care during cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO FR5, Reference H74908526032) in response to a manufacturing defect. The FDA has classified this as a Class I recall. Certain batches of these cardiac catheters contain a manufacturing defect affecting the polyurethane layer, which has been observed to delaminate and, in some cases, detach from the catheter's inner lining.
This defect can prevent proper advancement of the guidewire through the device lumen, potentially compromising the angiographic procedure or rendering the catheter non-functional when needed.
Approximately 15,079 catheters are affected by this recall. Distribution was worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific countries and regions. The affected batches are: 60429295, 60452070, 60467044, 60475390, 60491910, 60525061, 60430929, 60459221, 60472581, 60483688, 60498233, 60530044, 60512378, and 60536198 (Device UDI/DI: 08714729187707).
Healthcare providers with affected catheters should take appropriate steps to identify and manage potentially affected stock. Individuals who have received this device should consult with their healthcare provider for guidance.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 15,079
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 (15)
- UDI/DI 08714729187707
- Batch Numbers: 60429295
- 60452070
- 60467044
- 60475390
- 60491910
- 60525061
- 60430929
- 60459221
- 60472581
- 60483688
- 60498233
- 60530044
- 60512378
- 60536198
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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