Boston Scientific cardiac catheters recalled for delaminating polyurethane and guidewire advancement failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to complaints of guidewire advancement problems and polyurethane delamination in the catheter lining. Affected catheters are 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 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: This is an FDA Class I recall, the FDA's highest level of device recall, indicating a serious potential for adverse health consequences or death based on the material defects identified. The polyurethane delamination and material detachment directly compromise the guidewire advancement function essential to cardiac catheterization procedures.
Plain-English summary
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters, cardiac medical devices used in angiographic procedures. The recall covers 8,579 catheters from specific batch numbers distributed worldwide including the United States, U.S. Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
This FDA Class I recall is based on an increase in complaints about the device. Users have reported an inability to advance the guidewire through the device's inner lumen. Examination of affected catheters revealed polyurethane layer delamination and material detachment in the catheter lining in some instances.
The guidewire advancement function is essential for proper operation of these devices during angiographic procedures. The delamination and material detachment defects directly affect this critical function.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 8,579
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 (20)
- UDI/DI 08714729187844
- Batch Numbers: 60432312
- 60448988
- 60448989
- 60459201
- 60464505
- 60465484
- 60467102
- 60467103
- 60467104
- 60467105
- 60467106
- 60467107
- 60467121
- 60469088
- 60477210
- 60477211
- 60477213
- 60479437
- 60479438
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 · guidewire advancement failure
See all →- SevereExpo 5F cardiac catheters recalled for material delamination worldwide
FDA (Devices) · 2024-05-22
- SevereExpo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereExpo 5F Selective Angiographic Catheters Recalled for Material Delamination
FDA (Devices) · 2024-05-22
- SevereCardiac catheters recalled for guidewire advancement failure due to material delamination
FDA (Devices) · 2024-05-22
- SevereExpo Cardiac Catheters Recalled Due to Delamination and Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
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