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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
- Hazard
- distal-tip-separation
- device-defect
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
Distributed in 30 states:
- AL
- AZ
- CA
- DE
- FL
- GA
- IA
- IL
- IN
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- NC
- ND
- NJ
- NY
- OH
- OR
- PA
- RI
- SD
- TN
- TX
- UT
- VA
- WV
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