The Recall Desk

FDA (Devices) recall action 94270

ROUTE 92 MEDICAL INC recalled 5 products on 2024-05-01

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2024-05-01
Critical
1
Units
1,096

Why these products were recalled

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • SevereFDA (Devices)··2024-05-01

    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.

    Product
    Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Distribution
    30 states
  • SevereFDA (Devices)··2024-05-01

    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.

    Product
    Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Distribution
    30 states
  • SevereFDA (Devices)··2024-05-01

    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.

    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.
    Category
    Distribution
    30 states
  • CriticalFDA (Devices)··2024-05-01

    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.

    Product
    Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Distribution
    30 states
  • SevereFDA (Devices)··2024-05-01

    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.

    Product
    Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Distribution
    30 states