Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Route 92 Medical 070 Reperfusion System Recalled by ROUTE 92 MEDICAL INC Due to Their is the potential for distal tip separation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ROUTE 92 MEDICAL INC directly.
Affected Products
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Quantity: 19 units
Why Was This Recalled?
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Where Was This Sold?
This product was distributed to 30 states: AL, AZ, CA, DE, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OR, PA, RI, SD, TN, TX, UT, VA, WV
About ROUTE 92 MEDICAL INC
ROUTE 92 MEDICAL INC has 5 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report