Centerline Biomedical IOPS Guidewire 2 Coating Delamination Risk
Centerline Biomedical is recalling the IOPS Guidewire 2 (Lot 2404-2005) because the coating may delaminate during use, potentially compromising the guidewire's function during catheter placement procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I. Per the rubric, FDA Class I recalls are never scored below 4, and the structural/functional defect in a critical medical device (guidewire used during invasive vascular procedures) with potential to compromise device performance during use meets the Severe threshold.
Plain-English summary
Centerline Biomedical Inc. is recalling the IOPS Guidewire 2, model REF ATW-2, used to navigate through blood vessels during catheter placement. The guidewires in Lot 2404-2005 may experience coating delamination during use, which could affect their performance.
The affected units were distributed in the United States to Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, and Tennessee. The lot is identified by UDI/DI 00843152102037 and Lot Number 2404-2005. Approximately 80 units were distributed.
Patients and healthcare providers who have received or used these guidewires should contact Centerline Biomedical Inc. for instructions on replacement or return. Healthcare facilities should review their inventory and discontinue use of affected units from this lot.
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
- Affected units
- 80
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
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