Recall archive / FDA device enforcement
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package) — FDA record Z-1592-2023
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 Apr 5, 2023. 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
- WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
- Reason
- The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1300 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1592-2023
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 | GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 24, 2023
- Recall initiation date
- Apr 5, 2023
- Center classification date
- May 16, 2023
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.