CARDINAL HEALTH ASU1201Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10630140169700), received between Apr 18, 2018 and Sep 18, 2018 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2018Nonstandard Device; Obstruction of Flow

  THE SUCTION CANNULA IS BLOCKED WHEN IT IS ON CONTINUOUS SUCTION.

  Patient problems: No Information

  MAUDE report 7887957 ↗
• MalfunctionAug 10, 2018Mechanical Problem

  THE ISSUE WAS MET WITH 3 MEDICAL DEVICES OF THIS TYPE: A LACK OF ASPIRATION AND WASHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7773297 ↗
• MalfunctionJun 19, 2018Partial Blockage; Nonstandard Device

  THE SUCTION BUTTON FOR ASPIRATION STAYS BLOCKED. THE BUTTON DOESN'T GO UP AFTER A PERIOD OF TIME WHEN THERE IS A LOT OF BLOOD ASPIRATION DURING INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7614975 ↗
• MalfunctionJun 1, 2018Failure to Read Input Signal

  CONTINUOUS SUCTION WITHOUT PRESSING THE SUCTION PISTON ON THE TRUMPET VALVE, THE RED CONTROL BUTTON DIDN'T WORK.

  Patient problems: No Information

  MAUDE report 7562833 ↗
• MalfunctionMay 16, 2018Defective Device

  HEPATECTOMY IN LAPAROSCOPY PROCEDURE. HYDROLINE PROBES TESTED PRIOR TO BE USE AND WERE REPORTED TO BE FUNCTIONAL, BUT AFTER FEW PRESSURES THE VALVE BECAME DEFECTIVE. 3 DIFFERENT PROBES USED ON THE SAME PATIENT. THE SUCTION PISTON HAS BEEN COMPLETELY BLOCKED 3 TIMES IN A ROW WITH 3 DIFFERENT DEVICES DURING AN INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7518918 ↗
• MalfunctionApr 20, 2018Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7447143 ↗
• MalfunctionApr 20, 2018Suction Problem

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447140 ↗
• MalfunctionApr 19, 2018Suction Problem

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444184 ↗
• MalfunctionApr 19, 2018Failure to Read Input Signal

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7444161 ↗
• MalfunctionApr 19, 2018Suction Problem

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7442908 ↗
• MalfunctionApr 19, 2018Device Inoperable; Suction Problem

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7442850 ↗
• MalfunctionApr 18, 2018Mechanical Problem; Failure to Read Input Signal

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441470 ↗
• MalfunctionApr 18, 2018Suction Problem

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7440446 ↗
• MalfunctionApr 18, 2018Failure to Read Input Signal

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7440293 ↗
• MalfunctionApr 18, 2018Suction Problem

  THE CUSTOMER CLAIMS THAT AFTER PRIMING THE DEVICE FOR USE, THE SUCTION BUTTON WOULD NOT RELEASE RESULTING IN CONTINUED SUCTION REQUIRING THEM TO REPLACE THE SYSTEM WITH A NEW ONE. IT WAS REPORTED THAT THE PATIENT WAS NOT AT RISK. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7440085 ↗