FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
- Recall number
- Z-1652-2024
- Recalling firm
- Boston Scientific Corporation
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
- Status
- Open, Classified
- Initiated
- 2024-03-21
- Posted
- 2024-05-10
- Terminated
- not on file
- Reason
- An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- Root cause
- Under Investigation by firm
- Action
- Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/21/2024 via overnight delivery. The notice explained the issue, the potential risk, and requested the removal of the affected products. Distributors were directed to notify their consignees.
- Quantity
- 8725 catheters
- Distribution
- Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
- Lot, serial or model codes
- UDI/DI 08714729376675, Batch Numbers: 60433909, 60459200, 60467047, 60486322, 60504866, 60533642, 60447140, 60463976, 60474043, 60504859, 60517330
- 510(k) numbers
- ["K152605"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28