Route 92 Medical Reperfusion System Potential Catheter Tip Separation
Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.
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 classified as an FDA Class I recall. Although no injuries or illnesses have been reported, the potential for device component separation in a critical interventional catheter meets the Severe threshold per FDA classification guidelines.
Plain-English summary
Route 92 Medical, Inc. is recalling the Full Length 070 Reperfusion System (REF: 7001), a sterile, single-use medical device used to introduce interventional devices into the neurovasculature.
The recalled devices have the potential for distal tip separation at the proximal marker band of the delivery catheters. This defect could compromise device performance during clinical use.
Approximately 750 units have been distributed across the United States and New Zealand. The affected lot numbers are: 223060102, 24010102, 23070501, 24010903, 23082802, 24011606, 23100404, 24012403, and 23110901.
Facilities that have received this device should identify units with the affected lot numbers and contact Route 92 Medical, Inc. for recall information and guidance.
The recalled product
- Product
- Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
- Manufacturer
- ROUTE 92 MEDICAL INC
- Hazard
- Affected units
- 750
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 (8)
- UDI: 00853799007497/ Lot # 223060102
- 24010102
- 23070501
- 24010903
- 23082802 24011606
- 23100404
- 24012403
- 23110901
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
FDA (Devices) · 2024-05-01
- SevereRoute 92 Medical delivery catheter recalled due to tip separation risk
FDA (Devices) · 2024-05-01
- SevereRoute 92 Medical Reperfusion System Recalled for Potential Device Separation
FDA (Devices) · 2024-05-01
- CriticalRoute 92 Medical 070 Access System Recalled for Distal Tip Separation Risk
FDA (Devices) · 2024-05-01
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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