Route 92 Medical Access System Recalled for Distal Tip Separation
Route 92 Medical's Full Length 070 Access System (REF 7002) is recalled due to potential distal tip separation at the proximal marker band of the delivery catheters. This FDA Class I recall affects a device used in neurovasculature interventions distributed across the US 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 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: FDA Class I medical device recall. Per regulatory guidance, FDA Class I recalls mandate a minimum severity score of 4. No deaths or injuries have been reported, preventing a higher classification.
Plain-English summary
Route 92 Medical Inc has recalled the Route 92 Medical Full Length 070 Access System (REF 7002), a medical device used for introducing interventional devices into the neurovasculature. The FDA has classified this as a Class I recall.
The recall was initiated due to a potential for distal tip separation at the proximal marker band of the delivery catheters. The device is identified by UDI 00853799007473 and Lot Number 23051901. Ten units were affected.
The recalled device was distributed to medical facilities in multiple US states (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, and West Virginia) and to New Zealand.
The recalled product
- Product
- Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
- Manufacturer
- ROUTE 92 MEDICAL INC
- Affected units
- 10
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 (1)
- UDI: 00853799007473/ Lot # 23051901
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
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