Expo Cardiac Catheters Recalled Due to Polyurethane Delamination and Material Detachment
Boston Scientific's Expo 5F Selective Angiographic Catheters are being recalled worldwide because the polyurethane layer is delaminating and detaching from the inner lining, preventing the guidewire from advancing through the device.
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 a Class I recall, the FDA's highest-risk classification, requiring a minimum severity rating of Severe per the rubric. The confirmed material delamination and inability to advance the guidewire represents a serious device malfunction that prevents medical procedures from being performed, though no patient injuries or deaths have been reported.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO TIG4, REF H749085262502) worldwide. The recall affects approximately 4,270 catheters distributed across the United States, US Territories, EMEA, Canada, LATAM, and Asia Pacific regions.
An increase in complaints has been reported regarding an inability to advance the guidewire through the catheter's lumen. Investigation revealed that the polyurethane layer in the catheters is delaminating and, in some cases, material from the inner lining is detaching.
Healthcare providers and institutions that have received these catheters should stop using the affected batches immediately. Users should reference the specific batch numbers provided: 60447162, 60461412, 60474054, 60486303, 60495529, 60511248, 60511234, and 60531435. Patients who may have received procedures with these catheters should consult with their healthcare providers.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 4,270
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 (9)
- UDI/DI 08714729886082
- Batch Numbers: 60447162
- 60461412
- 60474054
- 60486303
- 60495529
- 60511248
- 60511234
- 60531435
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 · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- CriticalBoston Scientific Recalls Imager II 5F Angiographic Catheters Due to Tip Detachment Risk
FDA (Devices) · 2020-04-01
- SevereCook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture
FDA (Devices) · 2016-08-31
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- SevereBoston Scientific steerable sheath devices recalled due to manufacturing defect risk
FDA (Devices) · 2024-04-03
- SevereBoston Scientific Recalls Fetch 2 Aspiration Catheters Due to Shaft Breaks
FDA (Devices) · 2016-04-27
- HighBoston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends
FDA (Devices) · 2015-12-30