Pantheris A400XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851354004387), received between Dec 5, 2019 and Dec 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2019Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  DURING ATHERECTOMY IN THE POPLITEAL ARTERY, THE PANTHERIS CATHETER CONTACTED AN INDWELLING VASCULAR STENT AND RESISTED RETRACTION. THE PHYSICIAN GAINED PEDAL ACCESS, ADVANCED A BALLOON RETROGRADE AND PERFORMED ANGIOPLASTY TO FREE THE CATHETER FROM THE STENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THE DEVICE WAS SUCCESSFULLY RETRIEVED, AND NO MISSING OR DETACHED COMPONENTS OF THE DEVICE WERE CONFIRMED. THE IFU OF THE PANTHERIS DEVICE INSTRUCTS USERS HOW TO IDENTIFY THE STRUTS OF AN INDWELLING VASCULAR STENT USING THE REAL-TIME OCT IMAGING COMPONENT OF THE PANTHERIS SYSTEM IN ORDER TO AVOID SUCH CONTACT.

  Patient problems: Peripheral Vascular Disease

  MAUDE report 9418309 ↗