Expo 5F Selective Angiographic Catheters Recalled for Polyurethane Delamination
Expo 5F Selective Angiographic Catheters are recalled because polyurethane layer delamination and material detachment prevent guidewire advancement. Approximately 297,479 affected catheters have been 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 mandates a minimum severity score of 4 per the rubric. No deaths or serious injuries have been reported, so the score does not escalate to 5.
Plain-English summary
Boston Scientific Corporation is recalling certain Expo 5F Selective Angiographic Catheters (Model 5F EXPO FR4, UDI/DI 08714729187691) due to evidence of polyurethane layer delamination and material detachment in the device's inner lining. Affected catheters exhibit an inability to advance the guidewire through the device lumen.
The recall involves multiple batch numbers and affects approximately 297,479 catheters distributed worldwide to the United States, U.S. Territories, Europe, Canada, Latin America, and Asia Pacific regions.
Healthcare providers should cease use of affected catheter batches and contact Boston Scientific and the FDA for device return procedures and replacement instructions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 297,479
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 08714729187691
- Batch Numbers: 60423767
- 60436637
- 60449962
- 60467488
- 60481586
- 60500723
- 60423768
- 60438203
- 60449964
- 60467118
- 60481588
- 60500724
- 60423772
- 60438204
- 60449961
- 60467489
- 60482882
- 60500725
- 60425130
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.
See all 48 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · polyurethane delamination
See all →- 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
- SevereExpo 5F Selective Angiographic Catheters recalled for delamination risk
FDA (Devices) · 2024-05-22
Similar recalls
- CriticalBoston Scientific Recalls Imager II 5F Angiographic Catheters Due to Tip Detachment Risk
FDA (Devices) · 2020-04-01
- SevereBoston Scientific steerable sheath devices recalled due to manufacturing defect risk
FDA (Devices) · 2024-04-03
- SevereCook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture
FDA (Devices) · 2016-08-31
- HighMedtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation
FDA (Devices) · 2025-01-22
- SevereBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28