Bio-Medicus™ 96530-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000116040), received between Apr 20, 2023 and Oct 27, 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.

• MalfunctionOct 27, 2023Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER REPORTED THAT THE DEVICE WAS SPLIT AT THE CONNECTOR END THROUGH THE CLAMP SITE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18018421 ↗
• 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 16776322 ↗

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