Inari Medical Recalls Triever20 Aspiration Guide Catheter for Valve Failure
Inari Medical is recalling 318 Triever20 Aspiration Guide Catheters because the hemostasis valve may fail to seal, causing loss of vacuum during thrombus aspiration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional failure that may result in suboptimal thrombus removal or prolonged procedures, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Inari Medical is recalling 318 units of the Triever20 Aspiration Guide Catheter, a component of the FlowTriever Retrieval/Aspiration System. The affected units are identified by UDI 00850291007079 and lot numbers 20010004, 20010005, and 20010008.
The recall is due to a potential defect where the hemostasis valve may fail to seal. This failure can result in a loss of vacuum during thrombus aspiration. If the problem is not detected, it may lead to suboptimal thrombus removal or require the procedure to be prolonged using another device.
The affected devices were distributed in the United States, including the District of Columbia and the following states: IA, GA, MO, MI, AZ, FL, NJ, MN, LA, PA, AL, OH, NY, WI, CA, TX, TN, NH, IL, NC, CT, CO, OK, OR, IN, MA, VA, KY, WA, MS, SC, UT, SD, ND, AR, ID, and DE. Healthcare providers should stop using the affected devices and contact Inari Medical for further instructions.
The recalled product
- Product
- Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
- Manufacturer
- INARI MEDICAL
- Category
- Medical Device — Catheter
- Affected units
- 318
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 (3)
- Lot: 20010004
- 20010005
- 20010008
Distribution
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