---
title: "Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to na... — FDA record Z-1760-2025 | Is It on Recall"
description: "Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire."
url: https://isitonrecall.com/recall/fda-device-z-1760-2025-centerline-biomedical-iops-guidewire-2-ref-atw-2-sensorized-wire-used-to-navigate-through-vasculatur/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate... — FDA record Z-1760-2025

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 11, 2025. 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**: Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
- **Reason**: Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
- **Classification**: Class I
- **Recalling firm**: Centerline Biomedical Inc
- **Quantity**: 80 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1760-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1760-2025%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 00843152102037, Lot Number 2404-2005 |

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

## Distribution

US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Florida](https://isitonrecall.com/state/florida/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Mexico](https://isitonrecall.com/state/new-mexico/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: May 28, 2025
- **Recall initiation date**: Apr 11, 2025
- **Center classification date**: May 19, 2025

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-1760-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Centerline Biomedical Inc records](https://isitonrecall.com/brand/centerline-biomedical-inc/)