Ellik Bladder Evacuator 004501Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741049057), received between Jun 12, 2018 and Aug 24, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER SEEMED TO BE EXPERIENCING SOME ISSUES WITH THE ELLIK EVACUATOR CRACKING OPEN DURING USE. THE ONES THEY RECENTLY PURCHASED WERE TO REPLACE SOME THAT WERE DOING THIS. HOWEVER, ONE OF THE NEW ONES ALSO SPLIT YESTERDAY. THEY ARE JUST TRYING TO TROUBLESHOOT WHAT COULD BE CAUSING THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283345 ↗
• MalfunctionAug 24, 2022Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER SEEMED TO BE EXPERIENCING SOME ISSUES WITH THE ELLIK EVACUATOR CRACKING OPEN DURING USE. THE ONES THEY RECENTLY PURCHASED WERE TO REPLACE SOME THAT WERE DOING THIS. HOWEVER, ONE OF THE NEW ONES ALSO SPLIT YESTERDAY. THEY ARE JUST TRYING TO TROUBLESHOOT WHAT COULD BE CAUSING THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283171 ↗
• MalfunctionMay 14, 2020Naturally Worn; Contamination /Decontamination Problem; Naturally Worn

  IT WAS REPORTED THAT THERE WAS DEBRIS EXITING FROM THE BULB. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23 APRIL 2020 FROM A BD ASSOCIATE, THE CUSTOMER HAD BEEN USING THE PRODUCT FOR 5 YEARS AND THE BULB THAT IS MADE OF RUBBER PEELED. THIS WAS AN OVERUSE OF THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10059012 ↗
• MalfunctionJun 12, 2018Degraded

  IT WAS REPORTED THAT THE RUBBER BULB ON THE REUSABLE ELLIK EVACUATOR DEGRADES OVER TIME. IT WAS NOTED THAT THE REUSABLE ELLIK EVACUATORS WERE STERILIZED USING AN AUTOCLAVE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7591970 ↗