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U.S. Department of Health and Human Services

Class 1 Device Recall Centerline Biomedical

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 Class 1 Device Recall Centerline Biomedicalsee related information
Date Initiated by FirmApril 11, 2025
Date PostedMay 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1760-2025
Recall Event ID 96697
510(K)NumberK190106 K230309 K241243 K242133 K243842 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductCenterline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Code Information UDI/DI 00843152102037, Lot Number 2404-2005
FEI Number 3012154226
Recalling Firm/
Manufacturer		 Centerline Biomedical Inc
10000 Cedar Ave
Cleveland OH 44106-2119
For Additional Information ContactKevin Reed
330-577-5033
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionCenterline 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: kevin.reed@centerlinebiomedical.com.
Quantity in Commerce80 units
DistributionUS distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQK
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