Bio-Medicus™ 96530-119 (UDI 00763000947088)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000947088), received between Feb 26, 2026 and Apr 16, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 16, 2026Material Deformation

  IT WAS REPORTED THAT DURING USE OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, THE DEVICE WAS NOT PERFORMING EFFECTIVELY (POOR EFFECT). THE CANNULA WAS REMOVED, AND DEFORMATION OF THE CANNULA BODY WAS OBSERVED AFTER REMOVAL. THE CANNULA WAS REPLACED WITH ANOTHER PRODUCT. IT WAS UNKNOWN IF THERE WAS ANY COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902634 ↗
• InjuryMar 9, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA TIP WAS SHARP AND RELATIVELY HARD, MAKING IT PRONE TO VASCULAR INJURY DURING PUNCTURE AND INSERTION.THE CANNULA WAS USED TO ESTABLISH CARDIOPULMONARY BYPASS, AND AN AORTIC DISSECTION OCCURRED. UNDER ULTRASOUND GUIDANCE, THE ARTERY WAS CANNULATED USING THE PUNCTURE METHOD. THE PATIENT SUFFERED ARTERIAL INJURY, RESULTING IN AN AORTIC DISSECTION. THE PATIENT WAS URGENTLY TRANSFERRED TO THE OPERATING ROOM FOR DESCENDING AORTIC STENT PLACEMENT. THE PATIENT'S CONDITION GRADUALLY IMPROVED AND THEY WERE DISCHARGED AFTER RECOVERY. THE DEVICE WAS REPLACED. THERE WAS NO FURTHER ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Aortic dissection; Vascular Dissection

  MAUDE report 24543641 ↗
• InjuryFeb 26, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL CANNULA, IT WAS REPORTED THAT AORTIC PERFUSION WAS PERFORMED VIA THE FEMORAL ARTERY CANNULA, AND AORTIC DISSECTION OCCURRED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO FURTHER ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. IT WAS ALSO REPORTED THAT THE EVENT MAY BE RELATED TO THE UNIQUE VASCULAR CONDITIONS IN THIS PARTICULAR CASE AND THE CANNULATION TECHNIQUE. NO QUALITY DEFECTS HAD BEEN IDENTIFIED.

  Patient problems: Aortic dissection; Vascular Dissection

  MAUDE report 24451655 ↗

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