Boston Scientific Cardiac Catheters Recalled for Inner Lining Delamination
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the inner lining, which can prevent guidewire advancement.
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 establishes a minimum severity of 4 per the rubric. While no illnesses or injuries are reported in the source, the polyurethane delamination and material detachment in this critical cardiac device can prevent proper device function during invasive procedures, creating serious risk to patient safety.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO MULTIPACK 145) due to delamination of the polyurethane layer and material detachment within the catheter's inner lining. These defects can prevent proper advancement of the guidewire through the device's lumen.
The affected catheters have batch numbers 60447165, 60490140, and 60490183, identified by UDI/DI 08714729249429. The recalled devices total 1,950 units and were distributed worldwide, including the United States, US Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions.
Healthcare facilities should discontinue use of the affected batches immediately and contact Boston Scientific for replacement or other corrective measures. Patients with concerns about procedures performed with these catheters should consult their healthcare provider.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,950
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 (4)
- UDI/DI 08714729249429
- Batch Numbers: 60447165
- 60490140
- 60490183
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 · delamination
See all →- HighVascular grafts recalled after delamination reports prompt instructions for use update
FDA (Devices) · 2025-10-08
- SevereAngiographic Catheters Recalled for Polyurethane Delamination and Malfunction
FDA (Devices) · 2024-05-22
- SevereBoston Scientific Cardiac Catheters Recalled for Material Delamination
FDA (Devices) · 2024-05-22
- SevereExpo 5F Cardiac Catheters recalled due to delamination defect
FDA (Devices) · 2024-05-22
- CriticalCardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Issues
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
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- HighBoston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends
FDA (Devices) · 2015-12-30
- SevereBoston Scientific Recalls Chariot Guiding Sheaths Due to Shaft Separation
FDA (Devices) · 2015-12-30