---
title: "OptiCross Coronary Imaging Catheter, REF H749518080120 — FDA record Z-1396-2024 | Is It on Recall"
description: "Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image bright"
url: https://isitonrecall.com/recall/fda-device-z-1396-2024-opticross-coronary-imaging-catheter-ref-h749518080120/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# OptiCross Coronary Imaging Catheter, REF H749518080120 — FDA record Z-1396-2024

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 5, 2024. 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**: OptiCross Coronary Imaging Catheter, REF H749518080120
- **Reason**: Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
- **Classification**: Class II
- **Recalling firm**: Boston Scientific Corporation
- **Quantity**: 239 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1396-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1396-2024%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 08714729938415, Lot Numbers: 32426901, 32429407, 32625286 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution to the country of Japan.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Apr 3, 2024
- **Recall initiation date**: Mar 5, 2024
- **Center classification date**: Mar 28, 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.

## 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-1396-2024%22)

## Related records

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