Expo 5F Selective Angiographic Catheters recalled due to material delamination
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane layer delamination that prevents guidewire advancement. The inner lining material may detach, making the catheters unsafe to 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 classification mandates a minimum Severe rating. The delamination and material detachment prevent guidewire advancement, creating a critical functional failure during cardiac catheterization procedures.
Plain-English summary
Boston Scientific Corporation is recalling certain batches of Expo 5F Selective Angiographic Catheters (model 5F EXPO FR5 [SGL], reference number H74908526031) due to polyurethane layer delamination. The defect causes material detachment in the inner lining of the catheters, which prevents guidewire advancement through the catheter lumen.
The affected catheters are identified by UDI/DI 08714729366478 and batch number 60466921. These catheters were distributed worldwide, including to the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
Healthcare facilities and providers using these catheters should be aware of this defect. Questions or concerns should be directed to Boston Scientific Corporation.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
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 (2)
- UDI/DI 08714729366478
- Batch Numbers: 60466921
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 · material delamination
See all →- SevereExpo 5F cardiac catheters recalled for material delamination worldwide
FDA (Devices) · 2024-05-22
- SevereExpo 5F Catheters Recalled for Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereExpo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereExpo 5F Angiographic Catheters Recalled for Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereCardiac Catheters Recalled Due to Material Delamination and Guidewire Failure
FDA (Devices) · 2024-05-22
Similar recalls
- SevereBoston Scientific steerable sheath devices recalled due to manufacturing defect risk
FDA (Devices) · 2024-04-03
- CriticalBoston Scientific Recalls Imager II 5F Angiographic Catheters Due to Tip Detachment Risk
FDA (Devices) · 2020-04-01
- SevereBoston Scientific Recalls Chariot Guiding Sheaths Due to Shaft Separation
FDA (Devices) · 2015-12-30
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- SevereCook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture
FDA (Devices) · 2016-08-31
- SevereBoston Scientific Steerable Sheath Recalled Due to Potential Air Embolism Risk
FDA (Devices) · 2026-07-29