Maximum™ 406253Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734008402), received between Jul 13, 2018 and Mar 15, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2019Material Separation; Material Separation

  DURING THE PROCEDURE, THE INTRODUCER HUB AND SHEATH SEPARATED. THE DEVICE WAS RETRIEVED, AND ANOTHER INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425205 ↗
• MalfunctionJul 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  WHEN USING THE 8F MAXIMUM HEMOSTASIS INTRODUCER THE HEMODYNAMIC VALVE WAS LEAKY. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7688121 ↗