Expo 5F Selective Angiographic Catheters recalled for delamination risk
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in select batches due to polyurethane layer delamination and material detachment that could prevent guidewire advancement during use.
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 medical device recall for cardiac catheters with evidence of polyurethane delamination and material detachment that impairs guidewire advancement. Class I recalls are classified as minimum Severe (4) per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, Model 5F EXPO LCB (5PK), Reference H749085261952. These are cardiac catheters used in angiographic procedures. The recall affects 5510 catheters distributed worldwide, including the US, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
The company has identified an increase in complaints regarding an inability to advance the guidewire through the catheter lumen in certain batches. Investigation revealed evidence of polyurethane layer delamination and, in some cases, material detachment within the catheter's inner lining. This defect could compromise the device's functionality during clinical use.
The affected batch numbers are: 60443926, 60463398, 60472605, 60473187, 60498234, 60524982, 60513387, 60533587, and 60535875. Healthcare facilities and clinicians who have these catheters in inventory should stop using them and contact Boston Scientific Corporation or the FDA for further guidance on returns and replacement options.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 5,510
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 (10)
- UDI/DI 08714729187790
- Batch Numbers: 60443926
- 60463398
- 60472605
- 60473187
- 60498234
- 60524982
- 60513387
- 60533587
- 60535875
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 · polyurethane delamination
See all →- SevereExpo 5F Selective Angiographic Catheters Recalled for Polyurethane Delamination
FDA (Devices) · 2024-05-22
- SevereExpo 5F Selective Angiographic Catheters Recalled for Material Delamination
FDA (Devices) · 2024-05-22
- SevereCardiac Catheters Recalled Due to Defective Polyurethane Layer
FDA (Devices) · 2024-05-22
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