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Recall Observatory FDA recall evidence

Device product

Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter

Z-1760-2025

April 11, 2025

Class I

Product summary

Firm
Centerline Biomedical Inc
Event
Event 96697
Status
Ongoing
Classification
Class I
Quantity
80 units
Official record key
device-enforcement:Z-1760-2025

Official wording

Reason: Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

Code information: UDI/DI 00843152102037, Lot Number 2404-2005

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.