Mammotome EXRecalls & reported problems across all models
Devicor Medical Products, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 2 models of Mammotome EX by Devicor Medical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between May 19, 2017 and May 8, 2025 — classified as 5 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Device Packaging Compromised” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Mammotome EX problems
Device problems
- Device Packaging Compromised13
- Unsealed Device Packaging10
- Device Operates Differently Than Expected3
- Material Fragmentation3
- Break2
- Failure to Obtain Sample2
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged Prior to Receipt by User1
Patient problems
- No Consequences Or Impact To Patient28
- Foreign Body In Patient7
- Injury1
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
Mammotome EX models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mammotome EX HH8BEXInstrument, Biopsy34 reports
- Mammotome EX HH11BEXInstrument, Biopsy3 reports
Recent Mammotome EX adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryMar 31, 2021No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED BY THE AFFILIATE THAT BLACK MATERIAL WAS FOUND MIXED IN THE TISSUE SAMPLES RETRIEVED FROM THE PATIENT. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 11600505 ↗MalfunctionNov 23, 2020Break; Break
IT WAS REPORTED BY THE AFFILIATE THAT BEFORE A PROCEDURE FOREIGN MATERIAL (SMALL PARTICLES) FOUND ON THE CUTTER. NO PATIENT CONSEQUENCES REPORTED. THIS INCIDENT HAS BEEN DOCUMENTED AS COMPLAINT #: (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 10889530 ↗MalfunctionNov 23, 2020Break; Break
IT WAS REPORTED BY THE AFFILIATE THAT DURING A PROCEDURE, AFTER 1-5 CUTS, DEFECTS ON THE CUTTER. SOME METAL PARTICLES FELL OFF DURING THE PROCEDURE, AND MIXED WITH TISSUES. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT CONSEQUENCES REPORTED. THIS INCIDENT HAS BEEN DOCUMENTED AS COMPLAINT # (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 10885595 ↗MalfunctionJan 11, 2020Material Fragmentation; Material Fragmentation
IT WAS REPORTED BY THE AFFILIATE THAT DURING THE PROCEDURE , A VERY HARD FOREIGN MATTER WAS OBSERVED IN THE TISSUES DURING PROCEDURE. PROCEDURE WAS COMPLETED USING DEVICE WITH NO PATIENT COMPLICATIONS. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD NUMBER (B)(6).
Patient problems: Foreign Body In Patient
MAUDE report 9579349 ↗InjuryNov 15, 2019Material Fragmentation; Material Fragmentation
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT STATING THE KNOCKOUT TIP FELL OFF DURING PROCEDURE. THE BROKEN KNOCKOUT TIP ALMOST GOT INTO THE PATIENT THROUGH THE STEEL TUBE. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD NUMBER 11523686.
Patient problems: Foreign Body In Patient
MAUDE report 9331723 ↗InjuryJul 17, 2019Material Fragmentation; Material Fragmentation
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM AFFILIATE, DEVICOR MEDICAL (B)(4) LTD., STATING, THE EQUIPMENT WAS OPERATING NORMALLY, THE CAPITAL AND THE PROBE WERE CONNECTED. DURING THE PROCEDURE, WHEN THE USER PRESSED THE BIOPSY BUTTON, THE PLASTIC PART OF THE SPECIMEN COLLECTION CHAMBER WAS BROKEN AND GOT INTO THE PATIENT'S BREAST. THE USER WAS ABLE TO IDENTIFY THE PIECE USING ULTRASOUND AND REMOVE THIS PART AT THE NEXT BREAST TISSUE BIOPSY. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 8800033 ↗MalfunctionJul 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM AFFILIATE, DEVICOR MEDICAL DEVICE (B)(4) CO, LTD., STATING, "DURING PROCEDURE, VACUUM SET CARTRIDGE CONNECTED TO THE CAPITAL LOOSELY, AND FELL OFF EASILY. NO PATIENT CONSEQUENCES REPORTED". THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD #(B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8767645 ↗MalfunctionJul 1, 2019Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE DEVICOR MEDICAL DEVICE (B)(6), STATING, PRIOR TO PROCEDURE PACKAGING IS OPEN, HAS BREAK IN 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 8750599 ↗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 ↗MalfunctionJun 3, 2019Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE DEVICOR MEDICAL DEVICE SHANGHAI CO, LTD., STATING, PACKAGING IS OPEN, HAS BREAK IN 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 8662316 ↗MalfunctionJun 3, 2019Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE (B)(4), PACKAGING IS OPEN, HAS BREAK IN 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 8662309 ↗MalfunctionApr 10, 2019Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM OUR AFFILIATE DEVICOR MEDICAL DEVICE (B)(4), STATING, NEEDLE PACKAGING HAS BREAK IN 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 8501167 ↗MalfunctionJan 3, 2019Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS RECEIVED A REPORT FROM AFFILIATE, DEVICOR MEDICAL DEVICE SHANGHAI CO, LTD., STATING, NEEDLE PACKAGING HAS BREAK IN STERILE SEAL. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8214596 ↗MalfunctionNov 1, 2018Unsealed Device Packaging; Unsealed Device Packaging
(B)(4) STATING, NEEDLE PACKAGING HAS BREAK IN STERILE SEAL. NEEDLE HAS NOT BEEN OPENED AND USED. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8030695 ↗
Other Devicor Medical Products, Inc. products
All Devicor Medical Products, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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