Bard® Ellik Evacuator 000451Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741080814), received between Jun 5, 2017 and May 22, 2026 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Disconnection” (11 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Decrease in Suction

  IT WAS REPORTED BY CUSTOMER THAT THE DISPOSABLE BLADDER EVACUATOR WAS PUSHING BLADDER TUMOR PIECES BACK INTO THE BLADDER RATHER THAN REMOVING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25261447 ↗
• MalfunctionMar 10, 2026Wrong Label

  IT WAS REPORTED THAT THEY REQUIRED FURTHER CLARIFICATION REGARDING THE PRESENCE OF PHTHALATES IN THIS PRODUCT 000451. THE INFORMATION PROVIDED IN 2021 INDICATED THAT THIS PRODUCT DID NOT CONTAIN PHTHALATES. THEY THEREFORE NEED TO UNDERSTAND HOW AND WHY THE INCORRECT INFORMATION WAS PROVIDED. THEY WILL HAVE OUR QUALITY AND REGULATORY TEAMS PRESENT IN THE CALL WHO WOULD LIKE TO RAISE SOME ADDITIONAL QUESTIONS TO HELP US UNDERSTAND THE PROCESS. PER MDD THIS SYMBOL WOULD HAVE BEEN REQUIRED TO BE ON THE LABEL PER ERC 7.5 AS SHOWN BELOW BUT IT WAS NOT INCLUDED FOR SOME REASON. IT COULD BE THAT THE TRACKED MATERIAL IS NOT ACCURATE FOR THE END ITEM AS IT APPEARS TO NOT HAVE PVC OR PHTHALATES TRACKED MARKED. THEREFORE, THIS DEVICE WOULD HAVE BEEN CONSIDERED MISLABELED UNDER MDD. COULD SEE WHERE THIS POSSIBLY COULD BE A SA FOR THIS TYPE OF ERROR AND NEED QUALITY INVOLVEMENT. WE HAVE REALIZED THAT OUR MDD LABELS WERE OUT OF COMPLIANCE AND NEED TO REPORT THIS COMPLAINT. THE DATE OF AWARENESS IS FEB 25, 2025. AS THIS IS THE DATE WE FOUND THAT THE LABELS WERE OUT OF COMPLIANCE. THE ORIGINAL QUESTIONS CAME IN FROM A SUPPLIER ASKING ABOUT WHAT MATERIALS WERE IN OUR PRODUCTS AND THIS WAS NOT REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24564119 ↗
• MalfunctionOct 16, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE THE RUBBER TUBING ON THE EVACUATOR WAS DETACHING FROM THE BODY WHEN THE SURGEON WAS CLEARING OUT THE BLADDER. IT WAS USUALLY FINE THE FIRST TIME ROUND ON THE PATIENT BUT IF THEY NEED TO USE IT AGAIN IN THE SAME PROCEDURE, IT FALLS APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310023 ↗
• MalfunctionJul 23, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT CUSTOMER HAD SOME ISSUES WITH THE ELLIK BLADDER EVACUATOR BALL WHICH WAS NOT FIXING PROPERLY TO THE PLASTIC HOSE. THE DEVICE (BATCH NO. #NGJY0730) WAS USED WHILE THE PATIENT WAS ASLEEP ON THE OPERATION TABLE. ANOTHER DEVICE (BATCH NO. #NGJV5134) SOURCED FROM ANOTHER HOSPITAL AND TESTED IN THEATER WITH NO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576226 ↗
• InjuryFeb 18, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE, THE ELLIK EVACUATOR DISCONNECTED WHEN SQUEEZING TO RINSE BLADDER AND THEN SPLASHING SURGEON. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 05FEB2025, STATED THAT THE YES, SURGEON PERFORMING PROCEDURE HAD BODILY FLUID SPLASH INTO THE FACE, OTHER STAFF MEMBER HAD CLOTHING CONTAMINATED BY BODILY FLUIDS FROM PATIENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21400897 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ELLIK BLADDER EVACUATOR LEAKED AND SUCTION WAS VERY WEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450463 ↗
• InjuryMar 8, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE CRITICAL CARE NURSE REPORTED IN AN ONLINE SURVEY THAT "NO, THE ELLIK EVACUATOR WAS NOT SUCCESSFUL IN TISSUE AND/OR DEBRIS EVACUATION¿ BECAUSE "SOME BITS REMAINED, WHICH WERE REMOVED WITH THE RESECTOSCOPE" IN RELATION TO 00451: ELLIK BLADDER EVACUATOR DISPOSABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18864685 ↗
• MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT A UROLOGIST INDICATED "WATER LEAK FROM BOTTLE" PRIOR TO USAGE OF THE ELLIK EVACUATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720337 ↗
• MalfunctionDec 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DOCTOR WAS HAVING ISSUES WITH THE ELLIK DISPOSABLE BLADDER EVACUATOR WHERE IT WAS NOT SEALING THE WATER. THEY HAD GONE THROUGH 3 EACH SO FAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382818 ↗
• MalfunctionDec 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DOCTOR WAS HAVING ISSUES WITH THE ELLIK DISPOSABLE BLADDER EVACUATOR WHERE IT WAS NOT SEALING THE WATER. THEY HAD GONE THROUGH 3 EACH SO FAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346805 ↗
• MalfunctionJul 26, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ELLIK BLADDER EVACUATOR WAS BROKEN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17395794 ↗
• MalfunctionDec 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ELLIK EVACUATOR WAS STERILE BUT NOT MARKED ANYWHERE ON THE OUTER WRAP. PER ADDITIONAL INFORMATION RECEIVED ON 15NOV2022, IT WAS REPORTED THAT THE ELLIK EVACUATOR WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893086 ↗
• MalfunctionNov 18, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT THE ELLIK EVACUATOR WAS STERILE BUT NOT MARKED ANYWHERE ON THE OUTER WRAP. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2022, IT WAS REPORTED THAT THE ELLIK EVACUATOR WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824368 ↗
• MalfunctionNov 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PRESENCE OF A SUBSTANCE INSIDE THE ELLICK BULB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752211 ↗
• MalfunctionAug 31, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN ISSUE WITH THE ELLIK EVACUATOR. THE ADDITIONAL INFORMATION HAD BEEN REQUESTED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 21JUN2021, IT WAS STATED THAT THE SEAL DID NOT CLOSE PROPERLY, AND THIS ITEM COULD NOT BE USED. IT WAS CONFIRMED THAT THE DEVICE WAS AN ELLIK BLADDER EVACUATOR. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT INVOLVED DURING THIS ISSUE (NGCX1558). PER THE SAMPLE RECEIVED ON (B)(6) 2022, IT WAS NOTED THAT THE CUSTOMER RETURNED AN ADDITIONAL LOT (NGCU3572).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327647 ↗
• MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ELLIK EVACUATOR BULB WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960221 ↗
• MalfunctionOct 6, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN ISSUE WITH ELLIK BLADDER EVACUATOR. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 21JUN2021, STATED THAT THE SEAL DID NOT CLOSE PROPERLY AND THIS ITEM COULD NOT BE USED. THE DEVICE IS ELLIK BLADDER EVACUATOR. PATIENT WAS NOT INVOLVED DURING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584069 ↗
• MalfunctionAug 31, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE LATEX TUBING WAS DETACHED FROM THE ELLIK EVACUATOR AND DOES NOT HOLD IN PLACE SO THE DEVICE COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12403082 ↗
• MalfunctionAug 26, 2021Disconnection; Fitting Problem; Disconnection; Fitting Problem

  IT WAS REPORTED THAT THE CONNECTION PIECE OF THE ELLIK EVACUATOR WAS LOOSE AND WHEN TRYING TO CONNECT IT FOR FLUSHING, THE PIECE FELL OFF AND THAT THE ELLIK WAS USED IN THE TRANSURETHRAL RESECTION PROCESS. IT WAS ALSO STATED THAT THEY OPENED THE ENTIRE PACKAGE AND ALL THE ARTICLES HAD THE SAME DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370632 ↗
• MalfunctionAug 16, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ELLIK EVACUATOR BROKEN AT THE BASE WHEN INSERTED INTO THE HOSE TO DRAIN URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328785 ↗
• MalfunctionJul 26, 2021Off-Label Use; Difficult to Remove; Off-Label Use; Difficult to Remove

  IT WAS REPORTED THAT THE USER REMOVED THE TUBING OF ELLIK EVACUATOR BY PULLING IT OFF BECAUSE IT WAS TOO FLIMSY. DUE TO THIS ISSUE, THE SURGEON COMPLAINED THEY ATTACHED THEIR SILICONE ENDS, AND ALSO THEY NEEDED TO ATTACH THEM FOR THE OLYMPUS ADAPTOR TO FIT THE INSTRUMENT. THEY HAD TO GIVE IT A BIT OF TUG TO REMOVE IT, BUT THEY HAD BEEN DOING THIS FOR THE LAST FEW YEARS WITHOUT ANY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224259 ↗
• MalfunctionJun 28, 2021Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE ELLIK BLADDER EVACUATOR HAD BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081449 ↗
• MalfunctionApr 21, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE ELIK EVACUATOR OUTWEIGH THE RISKS BECAUSE OF DIFFICULTY WITH FITTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701755 ↗
• MalfunctionMar 31, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL STATED THAT IT WAS DIFFICULT TO FIT THE BARD ELLIK EVACUATOR INTO THE RESECTOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596759 ↗
• MalfunctionNov 26, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A LARGE PLASTIC CHIP WAS PRESENT IN THE ELLIK PEAR WHEN IT WAS OPENED FROM THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10909625 ↗