Catheter, Percutaneous, Neurovasculature
FDA adverse event reports and recall history for catheter, percutaneous, neurovasculature (product code QJP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,560
- Deaths
- 47
- Injuries
- 255
- Malfunctions
- 1,258
Reports per year
Source: FDA adverse event reports by year received, 2020–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-02-26Open, ClassifiedUnder Investigation by firm
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
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.
- 2024-10-07Open, ClassifiedUnder Investigation by firm
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 proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
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.
- 2024-05-28Open, ClassifiedProcess design
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.
- 2024-04-24Open, ClassifiedProcess control
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.
- 2024-04-24Open, ClassifiedProcess control
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
- 2024-03-13Open, ClassifiedUnder Investigation by firm
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
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.
- 2024-02-14Open, ClassifiedUnder Investigation by firm
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.
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