AXS INFINITY LS PLUS INC-11196-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327459180), received between Jan 31, 2019 and Jan 5, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryJan 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR A STROKE USING THE SUBJECT CATHETER. THE SUBJECT CATHETER UNRAVELED AT THE COIL AND BEGAN PULLING AWAY FROM THE CATHETER ITSELF. THE OUTER SHEATH OF THE CATHETER WAS BROKEN OFF. VASCULAR SURGEON WAS CALLED AND ASSISTED TO ¿CUT-DOWN¿ AT THE RADIAL ARTERY TO REMOVE THE CATHETER. ALL PART OF THE CATHETER WAS REMOVED FROM THE PATIENT ANATOMY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11115374 ↗
• MalfunctionJan 31, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS TRYING TO ADVANCE THE SUBJECT CATHETER INTO THE INTERNAL CAROTID ARTERY (ICA), THE CATHETER SPRUNG A LEAK AND THEN BROKE WHILE ABOUT 1 INCH OF THE CATHETER STICKING OUT OF THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8295157 ↗

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