Selective Angiographic Catheters recalled for material delamination and detachment
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect may prevent proper 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: This is an FDA Class I recall of a cardiac catheter with a documented manufacturing defect affecting guidewire advancement. The FDA Class I classification mandates a minimum Severe rating, as the defect poses a significant risk in a high-risk medical device application despite no reported illnesses or deaths.
Plain-English summary
Boston Scientific Corporation is recalling certain Expo 5F Selective Angiographic Catheters (Model 5F EXPO AL3) used in cardiac imaging procedures. The devices contain a polyurethane inner lining that may delaminate or detach during use.
The company has received complaints that the defect prevents proper advancement of the guidewire through the catheter lumen. Delamination and material detachment can compromise the device's functionality during cardiac imaging and interventional procedures.
Approximately 1,465 catheters from five batch numbers are affected: 60448983, 60461410, 60476253, 60486049, and 60517315. The devices were distributed worldwide to the U.S., U.S. territories, Europe, Canada, Latin America, and Asia Pacific regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,465
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 (6)
- UDI/DI 08714729187721
- Batch Numbers: 60448983
- 60461410
- 60476253
- 60486049
- 60517315
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
- 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
- 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 Recalls Fetch 2 Aspiration Catheters Due to Shaft Breaks
FDA (Devices) · 2016-04-27
- SevereBoston Scientific Recalls Chariot Guiding Sheaths Due to Shaft Separation
FDA (Devices) · 2015-12-30