AXS INFINITY LS PLUS INC-11196-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327459197), received between Nov 20, 2018 and Mar 22, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K172468, K193034); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2019Break; Break

  IT WAS REPORTED THAT DURING CAROTID STENTING PROCEDURE AT THE END OF THE CASE, AS THE LONG SHEATH CATHETER (SUBJECT DEVICE) WAS BEING REMOVED FROM THE PATIENT¿S BODY, THE LONG SHEATH CATHETER SHAFT BROKE BY THE HUB LOCATION. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8446440 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPOTED THAT UPON REMOVAL OF THE DEVICE, THE SHEATH STARTED TO STRETCH AND THE SHAFT WAS BROKEN. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172468, K193034. One submission often covers many models, so check the product and lot details in each record.

• Z-1708-2019 · Apr 18, 2019 · Terminated
  Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80