Route 92 Medical Reperfusion System Recalled for Potential Device Separation
Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.
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: This is an FDA Class I medical device recall, which indicates potential for serious adverse health consequences. Although no illnesses or injuries have been reported, the defect involves a stroke-treatment device where component failure could significantly compromise patient outcomes.
Plain-English summary
Route 92 Medical Inc. is recalling 19 units of the Route 92 Medical 070 Reperfusion System (REF 1003), which is used in the treatment of acute ischemic stroke. The system is designed to introduce interventional devices into blood vessels in the brain and to remove blood clots.
The devices are subject to recall due to a potential defect: the distal tip may separate at the proximal marker band of the delivery catheters. A separated tip could affect the device's ability to function properly during medical procedures.
The affected devices have lot numbers 23112702 and 23112901 (UDI: 00853799007169) and were distributed across the United States and New Zealand.
Healthcare providers should immediately discontinue use of affected devices and contact Route 92 Medical Inc. for guidance on device return and replacement.
The recalled product
- Product
- 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.
- Manufacturer
- ROUTE 92 MEDICAL INC
- Affected units
- 19
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: 00853799007169/ Lot # 23112702 and 23112901
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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