Centerline Biomedical recalls IOPS Guidewire 2 (Lot 2404-2005) due to potential coating delamination during use. Affected units may require replacement to prevent complications.
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Centerline Biomedical is recalling a specific lot of their IOPS Guidewire 2 catheter navigation device because the coating might separate during use. This could lead to complications if the wire becomes unstable or malfunctions.
The coating on the guidewire may delaminate (separate) during use, potentially causing the wire to become unstable or malfunction. This could lead to complications during catheter placement procedures if the wire moves unexpectedly or fails to function properly.
Medical professionals who use the Centerline Biomedical IOPS Guidewire 2 (Lot 2404-2005) for catheter placement procedures are most at risk. Patients receiving these procedures may also be affected if the device malfunctions.
Check for the lot number 2404-2005 on the device. The product is a sensorized wire used for navigating blood vessels to place a catheter.
Look for the lot number 2404-2005 on the device to confirm if it is affected.
The recall is for a specific lot (2404-2005) where the coating may delaminate. Other lots may be safe, but the recall only applies to this lot number.
The recall does not specify a remedy, so check the lot number and contact Centerline Biomedical for further instructions.
The recalled product has the lot number 2404-2005 and is a sensorized wire used for navigating blood vessels to place a catheter.
We’ve drafted a message you can send Centerline Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-1760-2025 — Centerline Biomedical Centerline Biomedical Hello, I own a Centerline Biomedical that is covered by recall Z-1760-2025 from Centerline Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
