Expo 5F Selective Angiographic Catheters recalled for guidewire advancement failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that can prevent guidewire advancement during cardiac catheterization 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 designation applies. Per the rubric, FDA Class I recalls never score below 4. While the source text does not report actual illnesses or injuries, the device malfunction hazard—inability to advance the guidewire through the catheter lumen—represents a potential risk during critical cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling the Expo 5F Selective Angiographic Catheters (Model 5F EXPO CAS1, Reference H749085261712) due to a defect affecting certain batches. The polyurethane layer in these cardiac catheters can delaminate and detach from the inner lining, which can prevent the guidewire from advancing properly through the device during cardiac catheterization procedures.
The defect has been identified in catheter batch 60447174. These catheters have been distributed worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Healthcare providers and medical facilities using these catheters for cardiac procedures are affected.
Healthcare professionals should discontinue use of affected batches immediately and contact Boston Scientific and their local regulatory authorities for guidance on replacement or alternatives. Patients who may have received these catheters during cardiac procedures should consult their healthcare providers if they have concerns about their treatment.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 120
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 08714729187776
- Batch Numbers: 60447174
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 →- ModeratePhilips Azurion 3 M15 Medical Device Recall for Unspecified SSDs
FDA (Devices) · 2026-11-04
- ModeratePhilips Azurion 7 M20 Medical Device Recall for Unspecified SSDs
FDA (Devices) · 2026-11-04
- ModerateBoston Scientific Nalu Therapy Disc Firmware Defect Recall
FDA (Devices) · 2026-11-04
- HighPhilips Azurion 7 M12 Recalled for Unspecified Solid-State Drives
FDA (Devices) · 2026-11-04
- SevereVentec Ventilator Cable Recall Due to Potential Disconnection
FDA (Devices) · 2026-10-28
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
- HighBoston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends
FDA (Devices) · 2015-12-30
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- HighBoston Scientific Guider Softip XF Guide Catheter Recalled for Polymer Degradation
FDA (Devices) · 2018-08-15
- SevereBoston Scientific Recalls Fetch 2 Aspiration Catheters Due to Shaft Breaks
FDA (Devices) · 2016-04-27