Bio-Medicus™ 96820-108 (UDI 00763000116293)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000116293), received between Jun 21, 2023 and Aug 19, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Mechanical Problem; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50321400 ↗
• MalfunctionMar 25, 2026Mechanical Problem; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688891 ↗
• MalfunctionMar 25, 2026Mechanical Problem; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688834 ↗
• MalfunctionMar 25, 2026Mechanical Problem; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688737 ↗
• MalfunctionFeb 10, 2026Contamination; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL AND VENOUS CANNULA, THE DILATOR MET MORE RESISTANCE THAN USUAL DURING INSERTION INTO THE CANNULA AND THE RED CAP WAS DESCRIBED AS "STICKY." THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302848 ↗
• MalfunctionJan 13, 2026Material Deformation

  IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS NEXT GEN CANNULA, THE CANNULA BODY WAS DAMAGED/DEFORMED. IT WAS REPORTED THAT THE DEVICE WAS WARPED. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051773 ↗
• MalfunctionJan 13, 2026Material Deformation

  IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS NEXT GEN CANNULA THE OBTURATOR WAS DAMAGED/DEFORMED. THE OBTURATOR WAS DESCRIBED AS WARPED. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051503 ↗
• MalfunctionDec 19, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT INSERTION/REMOVAL ISSUES OCCURRED WITH THE BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL AND VENOUS CANNULA. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847412 ↗
• MalfunctionDec 10, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULA WITH INTRODUCER, IT WAS REPORTED THAT THE CUSTOMER COULD NOT INSERT THE STYLET INTO THE CANNULA. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766596 ↗
• MalfunctionNov 27, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF 2 BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL AND VENOUS CANNULAE, IT WAS REPORTED THAT THE OBTURATOR WAS UNABLE TO PASS THROUGH THE TIP OF THE CANNULA. TWO SEPARATE CANNULAS WERE OPENED FROM THE SAME LOT AND BOTH WERE DEFECTIVE. BOTH DEVICE'S WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666194 ↗
• MalfunctionNov 27, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF 2 BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL AND VENOUS CANNULAE, IT WAS REPORTED THAT THE OBTURATOR WAS UNABLE TO PASS THROUGH THE TIP OF THE CANNULA. TWO SEPARATE CANNULAS WERE OPENED FROM THE SAME LOT AND BOTH WERE DEFECTIVE. BOTH DEVICE'S WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666192 ↗
• MalfunctionNov 27, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE,A CANNULA, SPECIFICALLY THE BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULA, WAS FOUND TO HAVE A DAMAGED OR DEFORMED OBTURATOR. THE LOCATION OF THE DAMAGE WAS SPECIFIED AS THE OBTURATOR BEING MALFORMED. THE DEVICE WAS NOT USED, AND THERE WAS NO DAMAGE TO THE PACKAGING OR OTHER DEVICES IN THE SAME BOX. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20794443 ↗
• MalfunctionJun 21, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULA, IT WAS REPORTED THAT THE OBTURATOR APPEARED TO BE BENT/KINKED INSIDE THE CANNULA. SEE ATTACHED PHOTOS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE PACKAGING WAS INTACT AND NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169172 ↗

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