Route 92 Medical 070 Access System Recalled for Distal Tip Separation Risk
Route 92 Medical 070 Access System catheters are recalled for potential distal tip separation during neurovasculature procedures. The defect affects 117 units distributed across 30 US states and New Zealand.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recall per CDRH. The rubric explicitly classifies FDA Class I recalls as Critical due to inherent serious risk to human health. The potential for distal tip separation in neurovasculature interventions—where fragments could cause stroke, vessel perforation, or thromboembolism—represents serious adverse health consequences.
Plain-English summary
The Route 92 Medical 070 Access System (REF 1004) is a sterile, single-use catheter designed for introducing interventional devices into the neurovasculature. The FDA is recalling this device due to a potential defect: distal tip separation may occur at the proximal marker band during use.
This defect poses a serious risk to patients undergoing neurovasculature interventional procedures. A separated catheter tip could remain in the patient's vasculature and potentially cause vessel perforation, thromboembolism, stroke, or other serious neurological complications.
The recall affects 117 units with lot numbers 23061601, 24010306, 23081802, 24011801, 23100601, 24020801, and 23102601. These devices were distributed to healthcare facilities in Alabama, Arizona, California, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, and New Zealand.
Healthcare providers and facilities currently using this device should discontinue use immediately and contact Route 92 Medical for instructions on product return or replacement.
The recalled product
- Product
- Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
- Manufacturer
- ROUTE 92 MEDICAL INC
- Affected units
- 117
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 (6)
- UDI: 00853799007442/ Lot # 23061601 24010306
- 23081802
- 24011801
- 23100601
- 24020801
- 23102601
Distribution
Part of a larger recall action
This product is one of 5 recalled by ROUTE 92 MEDICAL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · ROUTE 92 MEDICAL INC
See all →- SevereRoute 92 Medical Access System Recalled for Distal Tip Separation
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- SevereRoute 92 Medical Reperfusion System Recalled for Potential Device Separation
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- SevereRoute 92 Medical Reperfusion System Potential Catheter Tip Separation
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Same hazard · distal tip separation
See all →- HighCordis SMART FLEX Biliary Stent System recalled for potential tip separation
FDA (Devices) · 2021-11-24
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