Bio-Medicus™ 96820-112Recalls & reported problems
Medtronic, Inc. · CANNULA 96820-112 BIO-MED ART 12FR · Class 2
All models of Bio-Medicus (59)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169623118), received between Dec 10, 2024 and Dec 10, 2024 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Material Separation1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULA, IT WAS REPORTED THAT DURING THE ARTERIAL CANNULATION, THE OBTURATOR OF THE ARTERIAL CANNULA DID NOT FORM A SUFFICIENT SEAL WITH THE CANNULA CAP. EXCESSIVE BLOOD LEAKED FROM AROUND THE OBTURATOR WHEN IT HAD BEEN PULLED BACK APPROXIMATELY AN INCH. NO CANNULA CHANGEOUT OCCURRED. THE OBTURATOR WAS REMOVED AND BYPASS CONNECTIONS CONTINUED AS NORMAL. ONCE THE ARTERIAL CANNULA WAS APPROPRIATELY CONNECTED TO THE PUMP, THE PATIENT WAS TRANSFUSED TO REPLACE LOST VOLUME.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20892099 ↗
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 · TerminatedGastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the applicati
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page