Recall archive / FDA device enforcement
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 — FDA record Z-1582-2022
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 Aug 9, 2022. 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
- Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
- Reason
- The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 184 devices (UPDATED)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1582-2022
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 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 31, 2022
- Recall initiation date
- Aug 9, 2022
- Center classification date
- Aug 25, 2022
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.