Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Issues
Boston Scientific is recalling 9,271 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that can prevent guidewire advancement. The defect was found in certain batches with worldwide distribution.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the agency's most serious classification level for medical devices. The polyurethane delamination causes documented device malfunction that prevents proper guidewire advancement during critical cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling 9,271 Expo 5F Selective Angiographic Catheters (model 5F EXPO AR2) due to defects in the catheter's polyurethane lining. In certain batches, the polyurethane layer is delaminating and material is detaching from the catheter's inner lining. This defect can prevent the guidewire from advancing through the catheter's lumen, which could compromise procedures that rely on precise catheter positioning.
These catheters were distributed worldwide, including in the United States, US Territories, Europe, Canada, Latin America, and Asia Pacific regions. The affected batch numbers are 60430930, 60447169, 60462004, 60475385, 60515237, 60525060, 60447168, 60461420, 60474038, 60486305, 60522598, 60531431, and 60540176. The FDA has classified this as a Class I recall, indicating a serious potential hazard to patients.
If you have these catheters, do not use them and contact Boston Scientific for return and replacement instructions. Healthcare facilities should quarantine stock from affected batches immediately. If a catheter from an affected batch has already been used in a procedure, inform your healthcare provider.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 9,271
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 (14)
- UDI/DI 08714729168874
- Batch Numbers: 60430930
- 60447169
- 60462004
- 60475385
- 60515237
- 60525060
- 60447168
- 60461420
- 60474038
- 60486305
- 60522598
- 60531431
- 60540176
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
- 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
- HighBoston Scientific Recalls IntellaTip MiFi XP Catheters Due to Tip Bends
FDA (Devices) · 2015-12-30
- HighFARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk
FDA (Devices) · 2026-07-29