---
title: "Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 — FDA record Z-1582-2022 | Is It on Recall"
description: "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."
url: https://isitonrecall.com/recall/fda-device-z-1582-2022-boston-scientific-guider-softip-xf-40-xf-8f-guide-catheter-ref-h965100440/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1582-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1582-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)