Catheter, Percutaneous, Neurovasculature

Plato 17 Microcatheter REF PL17-160-090

Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.

The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the

Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.

Trevo Trak 21 Microcatheter, Catalog: 90338

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.

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

Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.

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

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers:

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.