CLASS I ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report
IOPS Guidewire recalled by Centerline Biomedical
Centerline Biomedical is recalling Centerline Biomedical IOPS Guidewire 2, distributed in 8 states. The recall was initiated on 11 Apr 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1760-2025
- FDA event ID
- 96697
- Recalling firm
- Centerline Biomedical, Cleveland, OH
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Apr 2025
- FDA classified
- 19 May 2025
- Reported
- 28 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 11 Apr 2025 | Recall initiated by company | |
| 19 May 2025 | Classified by FDA | +38 days |
| 28 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Where it was distributed
US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
FloridaNorth CarolinaNew MexicoNew YorkPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Is IOPS Guidewire 2 recalled?
Yes. Centerline Biomedical recalled IOPS Guidewire 2 on 11 Apr 2025. The recall is Class I and its status is Ongoing. Recall number Z-1760-2025.
Why was it recalled?
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Which lots are affected?
UDI/DI 00843152102037, Lot Number 2404-2005
Where was it sold?
US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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