Recall archive / FDA device enforcement
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter — FDA record Z-1652-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 21, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
- 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.
- Classification
- Class I
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 8725 catheters
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1652-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 08714729376675, Batch Numbers: 60433909, 60459200, 60467047, 60486322, 60504866, 60533642, 60447140, 60463976, 60474043, 60504859, 60517330 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 22, 2024
- Recall initiation date
- Mar 21, 2024
- Center classification date
- May 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.