Centerline Biomedical Inc medical device recall: Centerline Biomedical IOPS Guidewire 2
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96697
- Recall initiated
- Apr 11, 2025
- Classified by FDA
- May 19, 2025
- Posted in Enforcement Report
- May 28, 2025
- Recalling firm
- Centerline Biomedical Inc
- Firm location
- Cleveland, OH, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Visit
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 11, 2025. FDA classified it 38 days later, on May 19, 2025. Distribution reported by FDA: US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Recalled products (1)
Z-1760-2025 Class I Ongoing
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Codes / lots: UDI/DI 00843152102037, Lot Number 2404-2005
Quantity: 80 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96697
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.