Keller Funnel 2 HA-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628043725), received between Jun 11, 2021 and Sep 14, 2026 — classified as 2 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Inadequate Lubrication” (34 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 14, 2024Open, Classified

   Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

   Z-1694-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break; Inadequate Lubrication

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764080 ↗
• MalfunctionAug 13, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243333 ↗
• MalfunctionMar 9, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545846 ↗
• MalfunctionMar 9, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545664 ↗
• MalfunctionMar 9, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545523 ↗
• MalfunctionMar 9, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545270 ↗
• MalfunctionMar 5, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS, WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515831 ↗
• MalfunctionMar 5, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515763 ↗
• MalfunctionMar 3, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " , WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS, WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492896 ↗
• MalfunctionMar 2, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS, WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491457 ↗
• MalfunctionFeb 25, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444294 ↗
• MalfunctionFeb 25, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE)". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444073 ↗
• MalfunctionFeb 24, 2026Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED ¿WHEN USING THE KELLER FUNNEL, IT DOES NOT SLIP DESPITE BEING WELL HYDRATED. THIS DEFORMED THE IMPLANT. THE SURGEON HAD TO TAKE ANOTHER IMPLANT AND A NEW KELLER FUNNEL." DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431550 ↗
• MalfunctionOct 29, 2025Improper or Incorrect Procedure or Method; Inadequate Lubrication; Improper or Incorrect Procedure or Method; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LESS LUBRICANT IN THE FUNNELS OR SOMETIMES BARELY ANY LUBRICANT. OFFICE HAS STATED " ... WE'VE NOTICED LATELY THAT THERE SEEMS TO BE LESS LUBRICANT IN THE FUNNELS... WHICH MAKES THE INSERTION MORE DIFFICULT, ESPECIALLY IF WE USE SIZERS AFTER THE DENTURES, SOMETIMES THERE IS ALMOST NO LUBRICANT AT ALL, AND VERY DIFFICULT TO GET THE DENTURES IN". LATER HEALTHCARE PROFESSIONAL REPORTED "LUBRICATING COATING NO LONGER SLIPPED AFTER THE FIRST USE (NEEDED TO USE IT FOR A FEW SIZERS + INSERT THE FINAL IMPLANTS, HAD TO OPEN NEW ONES DURING THE PROCEDURE". PROVIDER FURTHER CONFIRMED THIS COMPLAINT RELATES TO BREAST IMPLANTS NOT "DENTURES". PATIENT CONTACT WAS MADE. SIDE IS UNKNOWN. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23419854 ↗
• MalfunctionOct 28, 2025Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "WE WERE NOT ABLE TO PIPE IN THE IMPLANT USING KELLER FUNNEL", "IT APPEARS THAT THE INSIDE OF THE FUNNEL WAS NOT WELL LUBRICATED. WE COULDN'T EVEN PIPE THE IMPLANT INTO A BUCKET WITHOUT SIGNIFICANT DIFFICULTY LET ALONE PIPE IMPLANT INTO PATIENT'S CHEST WITH SMALL INCISION. WE USED A SMALLER IMPLANT SIZE TOO (285 AND 320) AND CUT THE FUNNEL BACK MULTIPLE TIMES WAY FURTHER THAN NECESSARY". BOTH FUNNELS CAME FROM THE SAME BOX". IT IS UNCLEAR IF THERE WAS PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23406128 ↗
• MalfunctionOct 28, 2025Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "WE WERE NOT ABLE TO PIPE IN THE IMPLANT USING KELLER FUNNEL", "IT APPEARS THAT THE INSIDE OF THE FUNNEL WAS NOT WELL LUBRICATED. WE COULDN'T EVEN PIPE THE IMPLANT INTO A BUCKET WITHOUT SIGNIFICANT DIFFICULTY LET ALONE PIPE IMPLANT INTO PATIENT'S CHEST WITH SMALL INCISION". IT IS UNCLEAR IF THERE WAS PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405987 ↗
• MalfunctionAug 13, 2025Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED " INABILITY TO ADEQUATELY PASS IMPLANT THROUGH DEVICE AND ABANDONED USE OF DEVICE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798022 ↗
• MalfunctionJul 8, 2025Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "ONCE THEY DROPPED THE IMPLANT INTO THE FUNNEL, THE IMPLANT WOULD NOT PROPEL INTO THE POCKET". DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436623 ↗
• MalfunctionJul 7, 2025Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "THE IMPLANT WOULD NOT PROPEL INTO THE POCKET". A BACKUP KELLER FUNNEL WAS USED TO COMPLETE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22416761 ↗
• MalfunctionMay 19, 2025Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED TWO KELLER FUNNELS ¿WERE NOT SLICK UPON USE¿. PATIENT CONTACT WAS NOT MADE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047632 ↗
• MalfunctionMay 19, 2025Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED TWO KELLER FUNNELS ¿WERE NOT SLICK UPON USE¿. PATIENT CONTACT WAS NOT MADE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047619 ↗
• MalfunctionDec 28, 2024Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Inadequate Lubrication; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED "LUBRICATION NEVER ACTIVATED" AND "DIDN'T HAVE THE LUBRICATION GEL" FOR TWO KELLER FUNNELS. PATIENT CONTACT DID NOT OCCUR. THE AFFECTED DEVICES HAVE BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031416 ↗
• MalfunctionDec 23, 2024Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Inadequate Lubrication; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED LUBRICATION NEVER WAS ACTIVATED, LUBRICATION GEL WAS NOT OBSERVED. DEVICE HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20999941 ↗
• MalfunctionOct 30, 2024Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE "NO LUBRICIOUS COATING TO PASS THE IMPLANT, UNABLE TO USE, NO PATIENT INCIDENT". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20575193 ↗
• MalfunctionMay 22, 2024Inadequate Lubrication; Inadequate Lubrication

  COMPANY REPRESENTATIVE REPORTED "THE IMPLANT DID NOT PROGRESS. IT SEEMED THE LINING WAS NOT ACTIVATED". DEVICE WAS NOT IMPLANTED WITH THIS KELLER FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369681 ↗