FDA Medical Device Recalls (openFDA)
Centerline Biomedical Inc: Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
- Recall number
- Z-1760-2025
- Recalling firm
- Centerline Biomedical Inc
- Product
- Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
- Status
- Open, Classified
- Initiated
- 2025-04-11
- Posted
- 2025-05-19
- Terminated
- not on file
- Reason
- Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
- 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: kevin.reed@centerlinebiomedical.com.
- Quantity
- 80 units
- Distribution
- US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
- Lot, serial or model codes
- UDI/DI 00843152102037, Lot Number 2404-2005
- 510(k) numbers
- ["K190106","K230309","K241243","K242133","K243842"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3012154226
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28