Bio-Medicus™ 96530-119 (UDI 00763000116033)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000116033), received between Apr 20, 2023 and Jul 3, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (K153598); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE PATIENT HAD BEEN INTUBATED AND VENTILATED FOR 7 DAYS WITH INCREASING VENTILATOR REQUIREMENTS. THE PATIENT WAS CANNULATED WITH A BIO-MEDICUS 19 FR ARTERIAL JUGULAR VENOUS ADULT CANNULA IN THE OPERATING ROOM (OR). CANNULATION ITSELF WAS UNEVENTFUL. THE ANAESTHETIST OBSERVED THE GUIDEWIRE ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND EVERYONE WAS HAPPY WITH BOTH THE INTERNAL JUGULAR (IJ) AND FEMORAL VENOUS POSITION. IT WAS NOTED ON TEE THAT THERE WAS A LARGE CLOT LOCATED IN THE RIGHT ATRIUM. HEPARIN WAS GIVEN PRIOR TO CANNULA INSERTION. THE GUIDEWIRE IN THE IJ WAS INSERTED OVER THE CENTRAL LINE WHICH THEN WAS REMOVED. THE BIO-MEDICUS DILATORS WERE USED AND A VERY SMALL SKIN INCISION WAS MADE WHILE THE LAST DILATOR WAS IN, JUST PRIOR TO THE FINAL CANNULA INSERTION. CANNULA INSERTION WENT SMOOTHLY AND NO OBSTRUCTION OR RESISTANCE TO INSERTION WAS OBSERVED. IJ LINE WAS CLAMPED WHILE THE FEMORAL VENOUS CANNULA WAS INSTALLED, AGAIN, NO ISSUES WERE NOTED. UPON CONNECTION OF THE IJ CANNULA TO THE EXTRA-CORPOREAL LIFE SUPPORT (ECLS) CIRCUIT CLOT WAS NOTED IN THE IJ CANNULA. THE CANNULATING PHYSICIAN LET THE CANNULA BLEED

  Patient problems: Exsanguination

  MAUDE report 17245890 ↗
• MalfunctionApr 20, 2023Crack; Material Deformation; Crack; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULAE, IT WAS REPORTED THAT THE TIP OF THE CONNECTORS ON THE CANNULAE WERE WHITE, STRESSED AND CRACKED. THE CANNULAE WERE NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776183 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153598. One submission often covers many models, so check the product and lot details in each record.

• Z-2739-2026 · May 25, 2026 · Open, Classified
  Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula