Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling Expo 5F catheters due to polyurethane delamination and material detachment preventing guidewire advancement. The recall affects approximately 16,797 catheters distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The polyurethane delamination and material detachment in the catheter's inner lining represent a device malfunction that could compromise cardiac catheterization procedures.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, Model 5F EXPO FR3.5, due to polyurethane layer delamination and material detachment in the catheter's inner lining. The defect compromises device functionality, specifically preventing proper advancement of the guidewire through the catheter lumen. Approximately 16,797 catheters are affected, identified by UDI/DI 08714729187684 and 20 specific batch numbers.
The recalled catheters were distributed worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Healthcare providers and patients who have received these devices should be aware of the potential risk of procedural failure or complications during angiographic procedures.
Patients and healthcare providers who have this device should contact Boston Scientific Corporation for further guidance on device replacement or management. Healthcare facilities should inventory their stock and consult with Boston Scientific regarding affected batches to ensure patient safety and prevent use of potentially defective catheters.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 16,797
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 (20)
- UDI/DI 08714729187684
- Batch Numbers: 60425778
- 60427745
- 60438674
- 60456279
- 60465785
- 60476456
- 60427256
- 60430877
- 60440972
- 60465783
- 60472599
- 60479447
- 60427594
- 60430933
- 60449235
- 60465784
- 60474047
- 60479448
- 60474048
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 →- 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
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
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