FLEX ADVANTAGE 65651-920CRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 50885380029088), received between Nov 26, 2018 and Feb 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Suction Problem; Suction Problem

  CUSTOMER REPORTED A "CLOSE CALL" WITH A BABY. THE SUCTION WASN'T WORKING. THE STAFF CONFIRMED CHECKING THAT THE SUCTION WAS WORKING WHEN IT WAS SETUP, BUT WHEN THEY WENT TO USE IT, IT WAS NOT WORKING. WHEN THEY GOT IT TO WORK, IT WAS TOO POWERFUL. MANUAL MANEUVERS USED TO REMOVE MUCUS PLUG FROM NEONATE. DELAY WAS SEVERAL SECONDS. CUSTOMER REPORTED NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 21438198 ↗
• MalfunctionJan 3, 2023Suction Failure; Suction Failure

  PATIENT WAS IN OR FOR TRIAL OF FORCEPS. AFTER BIRTH OF BABY REQUIRED SUCTIONING AT PANDA WARMER. SUCTION DID NOT WORK. NEONATAL RESUSCITATION EQUIPMENT CHECKED BY NURSES WHEN SETTING UP FOR ASSISTED BIRTH AND WAS NOTED TO BE FUNCTIONING. WALL SUCTION USED AS NEEDED. NO ADVERSE OUTCOME TO BABY. ISSUE WITH SUCTION ON PANDA WARMERS FUNCTIONING INTERMITTENTLY BROUGHT TO BIRTH UNIT LEADERSHIP ATTENTION BY A STAFF MEMBER. IT WAS NOTED THAT SUCTION WOULD BE CHECKED AND FUNCTIONING BY NURSE AND THEN WHEN NEEDED FOR USE IT WOULD NOT FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091791 ↗
• MalfunctionFeb 8, 2021Collapse; Improper or Incorrect Procedure or Method; Suction Failure

  FROM INFORMATION RECEIVED FROM THE CUSTOMER, THEY REPORTEDLY HAVE HAD ISSUES WITH THE SUCTION LINERS. THE SUCTION LINERS ARE COLLAPSING ON THEMSELVES AND FORMING A LOOSE BALL IN THE SUCTION CANISTERS. WHEN THIS HAPPENS THE SUCTION NO LONGER WORKS, AND A NEW LINER IS NEEDED. BASED ON INFORMATION RECEIVED FROM THE CUSTOMER DURING OUR INVESTIGATION THEY STATED, ¿THE PROBLEM HAS BEEN RESOLVED. THE ISSUE WAS ON OUR END. THE PLASTIC CONTAINER HAD FOAM TAPE INSIDE WHICH WAS CAUSING THE LINER TO MALFUNCTION.¿ BASED ON THE CUSTOMERS RESPONSE THERE WAS NO INJURY TO STAFF OR PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11298582 ↗
• MalfunctionOct 9, 2020Defective Component; Unintended Deflation

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE LINER DIDN'T FIT PROPERLY INTO OUTER CANISTER. REPORTEDLY THE LINER DEFLATES ON ITSELF. THE CUSTOMER STATED THEY WERE ABLE TO MOVE FORWARD WITH THE PROCEDURE AND THERE WAS NO INJURY TO PATIENT. FOLLOW UP CONVERSATION WITH END USER INDICATES INCORRECT LINER MAY HAVE BEEN USED (FLEX LINER INSIDE CRD OUTER CANISTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10655043 ↗
• MalfunctionSep 24, 2019Material Puncture/Hole; Suction Problem

  CUSTOMER REPORTED INADEQUATE SCOPE SUCTION DUE TO A SMALL HOLE IN THE CANISTER LINER DURING EGD VARICEAL BANDING PROCEDURE. THE PATIENT CONTINUED TO BLEED, AND WAS TRANSFERRED TO ICU. REPORTEDLY, THE BANDS WERE DIFFICULT TO PLACE DUE TO LACK OF SUCTION. WHEN CANISTER LINER WAS REMOVED BLOODY WATER AND SECRETIONS HAD BEEN PULLED AND THERE WAS BLOOD IN THE LINER AND CANISTER. LOT NUMBER -UNDEFINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9112928 ↗
• MalfunctionNov 26, 2018Detachment of Device or Device Component

  STAFF REPORTED DIFFICULTY SECURING THE 90 DEGREE ADAPTER TO THE TOP OF THE FLEXIBLE CANISTER. EVEN WITH DOWNWARD PRESSURE AND TWISTING MOTION, THE ADAPTER COULD TWIST OFF WITH EASE. AS A RESULT, THE ADAPTER FELL OFF DURING A PEDIATRIC CODE AND THE TEAM LOST SUCTION. THE PATIENT WAS NOT INJURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8103071 ↗