Centerline Biomedical IOPS Guidewire 2 Coating Delamination Risk Recall
Centerline Biomedical is recalling IOPS Guidewire 2 devices (Lot 2404-2005) because the coating may delaminate during use, potentially compromising device function in critical vascular procedures.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification for medical device with potential for failure during critical vascular procedures. Class I recalls indicate reasonable probability of serious adverse health consequences.
Plain-English summary
Centerline Biomedical Inc. is recalling the IOPS Guidewire 2 (REF ATW-2), a sensorized medical wire used to navigate through blood vessels to facilitate catheter placement.
The recall affects 80 units bearing Lot Number 2404-2005. The company has determined that the coating on these guidewires may delaminate during use, which could compromise device function during vascular procedures.
The affected devices were distributed to medical facilities in Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, and Tennessee.
The recalled product
- Product
- Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
- Manufacturer
- Centerline Biomedical Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- coating-delamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00843152102037
- Lot Number 2404-2005
Distribution
Distribution scope not specified by the agency.
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