Keller Funnel 2 HA-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628043732), received between Oct 5, 2023 and Nov 21, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Inadequate Lubrication” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Microbial Contamination of Device; Microbial Contamination of Device

  HEALTHCARE PROFESSIONAL REPORTED ¿WHEN THEY OPENED THE PACKAGING, KELLER FUNNEL HAD HAIR ON IT. THE FUNNEL WAS NOT USED¿. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622579 ↗
• InjuryJul 22, 2024Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED DEVICE "WOULD NOT ALLOW AN IMPLANT TO SLIDE IN DESPITE BEING CUT TO CORRECT MARKING FOR IMPLANT SIZE AND APPROPRIATE LUBRICATION. VERY STICKY AND STIFF AT END OF THE FUNNEL." SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

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

  MAUDE report 19792796 ↗
• MalfunctionFeb 6, 2024Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE "KELLER FUNNEL'S SEEMED TO BE STICKY INSTEAD OF LUBRICATED". DEVICE WAS NOT CONTACT WITH PATIENT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650343 ↗
• MalfunctionFeb 6, 2024Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE "KELLER FUNNEL'S SEEMED TO BE STICKY INSTEAD OF LUBRICATED". DEVICE DID NOT MAKE CONTACT WITH PATIENT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650204 ↗
• MalfunctionJan 4, 2024Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "BREAST IMPLANT WOULD NOT PASS THROUGH FUNNEL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445801 ↗
• MalfunctionJan 4, 2024Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "BREAST IMPLANT WOULD NOT PASS THROUGH FUNNEL." PATIENT CONTACT DID OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445657 ↗
• MalfunctionJan 4, 2024Inadequate Lubrication; Inadequate Lubrication

  HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "BREAST IMPLANT WOULD NOT PASS THROUGH FUNNEL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445589 ↗
• MalfunctionJan 2, 2024Inadequate Lubrication; Inadequate Lubrication

  PHYSICIAN REPORTED "THE SIZER WOULDN'T GO THROUGH" AGAINST THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 18428712 ↗
• MalfunctionOct 5, 2023Device Damaged by Another Device; Device Damaged by Another Device

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURED INSIDE THE KELLER FUNNEL BEFORE IMPLANTATION.¿ AFFECTED SIDE IS UNKNOWN. SURGERY WAS COMPLETED WITH BACKUP IMPLANT AND KELLER FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17880169 ↗