Bio-Medicus™ 96820-110 (UDI 00643169623101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169623101), received between Dec 18, 2018 and Jun 30, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THAT BLOOD WAS COMING OUT BEFORE THE DESIGNATED LINE ON THE BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULA. THE LEAK WAS FROM THE STOPPER WHERE THE STYLET IS INSERTED. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO IMPACT TO THE PATIENT ASSOCIATED WITH THE REPORTED EVENT. ADDITIONAL INFORMATION: BESIDES LOSING A LITTLE BLOOD, THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238805 ↗
• MalfunctionMar 8, 2023Material Twisted/Bent; Material Twisted/Bent

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA BODY WAS KINKED. THE DEVICE WAS REPLACED BEFORE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE KINK WAS NOT IN THE LOCATION OF THE SUTURES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE KINK WAS IN THE WIRE REINFORCED PORTION OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16502328 ↗
• InjuryDec 18, 2018Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING AN ECMO CASE USING A BIO-MEDICUS PEDIATRIC ARTERIAL CANNULA IT WAS NOTED ON THE FOURTH DAY THERE WAS BLOOD NOTED LEAKING FROM THE METAL STRIP ABOUT 1 CM FROM THE END OF THE METAL PART. THE BLEEDING INCREASED WITHIN A FEW SECONDS, ECMO WAS CLOSED, FULL VENTILATION WITH INCREASED ADRENALINE DOSE WAS BEGUN. THE PATIENTS BLOOD PRESSURE LOWERED, THEY LOST BLOOD, RECEIVED 2 DOSES OF ADRENALIN AND A PACK OF BLOOD CELLS. THE CANNULA WAS REPLACED AND PATIENT CONNECTED TO THE ECMO SYSTEM AGAIN. THE PATIENT HAS A EXACERBATION OF PULMONARY EDEMA. THE CUSTOMER NOTED THAT PATIENT HAD NORMAL MEASUREMENTS 5 MINUTES PRIOR TO THE LEAK. CUSTOMER COMMENTED THAT THE CANNULA DID NOT LOOK STRAIGHT WHEN REMOVED FROM THE PACKAGING.

  Patient problems: Pulmonary Edema

  MAUDE report 8174653 ↗

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