Mammotome elite MEP10Recalls & reported problems
Devicor Medical Products, Inc. · Probe - CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841911100881), received between May 22, 2019 and Aug 24, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Obtain Sample” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Obtain Sample1
- Unsealed Device Packaging1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING BREAST BIOPSY PROCEDURE. AFTER THE TISSUES WERE COLLECTED, THE SAMPLE CUP WAS OPENED AND A PIECE OF PLASTIC WAS FOUND, WHICH WAS NOT NOTICED DURING PRIMING. THE SIZE OF THE FOREIGN OBJECT WAS ABOUT 5 MILLIMETERS. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17613006 ↗MalfunctionAug 1, 2019Failure to Obtain Sample; Failure to Obtain Sample
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM AFFILIATE, DEVICOR MEDICAL (B)(4)" IN THE INITIALIZING PROCESS, THE PROBE WAS ATTACHED TO THE HOLSTER PROPERLY AND COMPLETED PRIMING, HOWEVER THE SPECIMEN WAS NOT TRANSPORTED TO THE CHAMBER". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8852881 ↗MalfunctionMay 22, 2019Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE (B)(4)., STATING, PACKAGE DAMAGED RESULTING IN BREACH OF STERILE SEAL. NO PATIENT INVOLVEMENT. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8631240 ↗
Other Instrument, Biopsy devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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