Mammotome EX HH11BEXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841911100942), received between Jul 26, 2017 and May 8, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Packaging Compromised” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033700); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED BEFORE THE PROCEDURE. WHEN THE PROBE WAS REMOVED FROM PACKAGING AND TRIED TO BE ATTACHED TO THE HOLSTER, A FOREIGN OBJECT FELL OUT OF THE AREA WHERE THE SPECIMEN WAS TO BE COLLECTED. THE PROCEDURE WAS COMPLETED WITH THE PROBE WITHOUT REPLACING IT. THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985347 ↗
• InjuryJun 27, 2019Use of Device Problem; Use of Device Problem

  DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM A USER FACILITY STATING, "DURING THE PROCEDURE THE PHYSICIAN HAD HER FINGER STUCK IN THE EX PROBE BETWEEN THE CUTTER AND THE END OF THE COLLECTION CHAMBER. SHE WAS UNABLE TO REMOVE HER FINGER, THE CUTTER WAS ADVANCED FORWARD AND LODGED SO HER FINGER COULD NOT BE REMOVED. WHEN IT JAMMED THEY HAD AN ERROR ON THE DEVICE SO THEY SHUT IT OFF AND REMOVED THE PROBE FROM THE BREAST." THE USER CONTACTED DEVICOR FOR INFORMATION ON HOW TO REMOVE THE PROBE FROM THE PHYSICIAN'S FINGER. THE USER WAS INSTRUCTED TO REMOVE THE PROBE FROM THE HOLSTER AND ADVISED TO SEEK ASSISTANCE WITH REMOVAL OF THE PROBE FROM THE PHYSICIAN'S FINGER IN THE EMERGENCY DEPARTMENT. THE PROBE WAS REMOVED FROM THE PHYSICIAN'S FINGER IN THE EMERGENCY ROOM. THIS HAS BEEN DOCUMENTED IN OUR SYSTEMS AS RECORD # (B)(4).

  Patient problems: Injury; Laceration(s)

  MAUDE report 8741337 ↗
• MalfunctionJul 26, 2017Device Packaging Compromised; Device Packaging Compromised

  THE (B)(6) AFFILIATE REPORTED THAT WHEN STAFF TOOK OUT THE SET FROM THE BOX, THE PACKAGING WAS TORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6744523 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033700. One submission often covers many models, so check the product and lot details in each record.

• Z-0440-05 · Dec 10, 2004 · Terminated
  Mammotome EX Holster