Fischer Cone Biopsy Excisor 900-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937003734), received between Feb 28, 2020 and Nov 17, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K061651); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2020Break; Melted

  E-COMPLAINT- (B)(4). REPORT STATED - DURING LEEP SURGERY, RUBBER TIP MELTED AND TIP BROKE." FISCHER CONE BIOP EX M EX 900-154 E-COMPLAINT- (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10853589 ↗
• MalfunctionFeb 28, 2020Break

  WIRE BROKE DURING USE. 1216677-2020-00059-1 FISCHER CONE BIOP EX M EX 900-154 E-COMPLAINT-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9769297 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061651. One submission often covers many models, so check the product and lot details in each record.

• Z-1612-2022 · May 25, 2022 · Open, Classified
  Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
• Z-1879-2018 · Mar 12, 2018 · Terminated
  Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151