Bio-Medicus™ 96820-108 (UDI 00643169623095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169623095), received between May 15, 2023 and Jul 10, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K143083); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE BIO-MEDICUS ARTERIAL CANNULAE, THE CUSTOMER NOTICED THAT THE OBTURATORS WERE JAMMED. SCRUB NOTICED THE ISSUE PRIOR TO HANDING CANNULA TO SURGEON. THEY TRIED TO GET IT TO WORK BY SOAKING THE CANNULA IN WARM WATER FIRST. THE CANNULAE WERE REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285496 ↗
• MalfunctionJul 10, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE BIO-MEDICUS ARTERIAL CANNULAE, THE CUSTOMER NOTICED THAT THE OBTURATORS WERE JAMMED. SCRUB NOTICED THE ISSUE PRIOR TO HANDING CANNULA TO SURGEON. THEY TRIED TO GET IT TO WORK BY SOAKING THE CANNULA IN WARM WATER FIRST. THE CANNULAE WERE REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285485 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULAE THE CUSTOMER NOTED THAT WHEN THE OBTURATOR WAS INTRODUCED INTO THE CANNULAE THE OBTURATOR WOULD BEND AND IT WOULD NOT PASS THROUGH THE TIP OF THE CANNULAE. THE CANNULAE WERE REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. THE CUSTOMER HAD THREE INSTANCES OF THIS OCCUR; TWO OF THEM WERE SAVED AND ARE BEING RETURNED AND ONE OF THEM WAS DISCARDED. ALL OF THE CASES OCCURRED ON THE SAME DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17256033 ↗
• MalfunctionMay 15, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE CANNULA WHEN THE CUSTOMER WAS PREPARING THE BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULA FOR INSERTION ON THE STERILE FIELD, THE SCRUB MOVED THE RUBBER RING ON THE TIP AND THE CANNULA SPLIT IN HALF. THE CANNULA WAS REPLACED WITH A CANNULA FROM ANOTHER LOT FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECTS OCCURRED. THE CUSTOMER STATED THAT THEY HAVE FOUR OTHER CANNULAE FROM THE SAME LOT NUMBER AND THEY DO NOT FEEL SAFE USING THEM AND HAVE PULLED THEM OFF THE SHELF FOR RETURN. THE SPLIT ONLY AFFECTED ONE OF THE FIVE CANNULAE. THE OTHER THREE CANNULAS WERE NOT OPENED AND ARE STILL IN STERILE PACKAGING. NO DAMAGE WAS NOTICED TO THE PACKAGING. THE CUSTOMER WOULD LIKE CONFIRMATION IT WAS JUST THE AFFECTED LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929648 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143083. One submission often covers many models, so check the product and lot details in each record.

• Z-0640-2018 · Sep 21, 2017 · Terminated
  GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the applicati