Expo 5F Cardiac Catheters recalled due to polyurethane delamination
Boston Scientific recalled 2,314 Expo 5F cardiac catheters due to polyurethane delamination in the inner lining. The defect can prevent guidewire advancement during angiographic 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this as a Class I recall. Class I recalls indicate a serious potential for adverse health consequences. The polyurethane delamination and material detachment prevent guidewire advancement, compromising the catheter's core functionality during critical cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling 2,314 Expo 5F Selective Angiographic Catheters (Model 5F EXPO WR, Reference H74908526501). The recall affects ten specific batch numbers and involves worldwide distribution including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
The catheters are experiencing polyurethane layer delamination and material detachment in the inner lining. This defect results in an inability to advance the guidewire through the catheter lumen, which can prevent proper device function during cardiac angiographic procedures.
Healthcare facilities and patients who received catheters in the affected batches may be impacted. The FDA classified this as a Class I recall, indicating a serious potential for adverse health consequences.
Healthcare providers should immediately discontinue use of affected catheter batches and consult the FDA safety notice for specific batch numbers. Patients who have received these devices should contact their healthcare provider for evaluation and guidance.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 2,314
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 (16)
- UDI/DI 08714729249399
- Batch Numbers: 60429298
- 60451469
- 60459243
- 60481409
- 60535930
- 60434211
- 60454956
- 60463953
- 60490141
- 60535931
- 60436616
- 60459198
- 60463979
- 60517312
- 60536204
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
- SevereExpo 5F Angiographic Catheters Recalled for Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereCardiac Catheters Recalled Due to Material Delamination and Guidewire Failure
FDA (Devices) · 2024-05-22
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