Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific recalled Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in certain batches, which can prevent guidewire advancement during cardiac 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 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 classification for this medical device recall. While no deaths or reported injuries are documented in the notice, the agency's Class I designation and the hazard of device malfunction during critical cardiac procedures warrant a Severe rating.
Plain-English summary
Boston Scientific Corporation has recalled Expo 5F Selective Angiographic Catheters (model 5F EXPO FL4) due to a defect in certain batches affecting their structural integrity.
The issue involves delamination of the polyurethane layer and detachment of material in the catheter's inner lining. This defect can prevent the guidewire from advancing through the catheter's lumen during angiographic procedures, which may compromise the procedure's effectiveness and patient safety.
Approximately 116,091 catheters across multiple batches have been distributed worldwide, including in the United States, U.S. Territories, Europe, Canada, Latin America, and Asia Pacific regions. Affected batch numbers are listed in the FDA recall notice.
If you are a healthcare provider who has used or has these catheters in inventory, contact Boston Scientific immediately regarding this recall. Do not use affected catheters with patients. Healthcare facilities should verify their inventory against the affected batch numbers provided by the manufacturer.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 116,091
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 08714729187820
- Batch Numbers: 60427721
- 60437784
- 60456288
- 60473154
- 60481598
- 60500737
- 60427722
- 60443032
- 60461431
- 60473157
- 60481599
- 60505121
- 60427723
- 60443033
- 60462014
- 60474023
- 60481600
- 60512236
- 60427724
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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