Route 92 Medical delivery catheter recalled due to tip separation risk
Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were 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 carries a minimum severity score of 4 per classification guidelines. No illnesses or injuries are reported in the source text.
Plain-English summary
Route 92 Medical Inc is recalling the Tenzing 7 Delivery Catheter (REF 1005), a prescription-only sterile medical device used to guide interventional tools into blood vessels in the neurovasculature.
The recall addresses a potential for the distal tip to separate at the proximal marker band. This defect could affect device function and compromise safety during use.
The recall affects 200 units distributed across the United States and New Zealand. The affected lot numbers are 23033001, 23073101, 23070305, and 23081707.
The recalled product
- Product
- Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
- Manufacturer
- ROUTE 92 MEDICAL INC
- Affected units
- 200
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 (4)
- UDI: 00853799007534/ Lot # 23033001
- 23073101
- 23070305
- 23081707
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
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- SevereRoute 92 Medical Reperfusion System Potential Catheter Tip Separation
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