510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1760-2025Class I

Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to...

Centerline Biomedical / initiated 2025-04-11 / Open, Classified
FDA source (opens on fda.gov)

Centerline Biomedical Inc began a recall of Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter on . FDA classified it as Class I and gives the reason as "Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1760-2025
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Centerline Biomedical
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Product code
DQK Computer, Diagnostic, Programmable
Reason for recall
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
FDA root cause
Under Investigation by firm
Action
Centerline Biomedical issued an "URGENT MEDICAL DEVICE RECALL" notice dated 4/11/2025 to its consignees on 04/11/2025 via hand delivery. The notice explained the issue with the device, potential risk to the patient and actions to be taken. The consignees were requested to Complete the Customer Acknowledgement letter in the possession of your Clinical Account Manager and return all affected products to Clinical Account Manager. For questions contact: Director Quality and Regulatory, Phone Number: (330) 577-5033, Email: [email protected].
Quantity in commerce
80 units
Distribution
US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Product codes and lots
UDI/DI 00843152102037, Lot Number 2404-2005

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1760-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1760-2025Class IOngoingVoluntary: Firm initiated