Mammotome EX HH8BEXRecalls & reported problems
Devicor Medical Products, Inc. · Probe and Vacuum Set - CE · Class 2
All models of Mammotome EX (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the Mammotome EX HH8BEX probe and vacuum set, a biopsy instrument used to collect breast tissue samples. Most of the 34 reports describe packaging that arrives opened or with a broken sterile seal, plus cutter parts breaking or shedding metal and plastic fragments that end up mixed into the tissue or left in the breast. Reports mention 4 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00841911100959), received between May 19, 2017 and Mar 31, 2021 — classified as 4 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Device Packaging Compromised” (12 reports).
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
Device problems
- Device Packaging Compromised12
- 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 Patient27
- Foreign Body In Patient7
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionOct 5, 2018Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS INC. RECEIVED A COMPLAINT FROM AFFILIATE, (B)(6) STATING, NEEDLE PACKAGING HAS BREAK IN STERILE SEAL. NEEDLE HAS NOT BEEN OPENED AND USED. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7938307 ↗MalfunctionOct 5, 2018Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS INC. RECEIVED A COMPLAINT FROM AFFILIATE, DEVICOR MEDICAL DEVICE (B)(4), LTD., STATING, NEEDLE PACKAGING HAS BREAK IN STERILE SEAL. NEEDLE HAS NOT BEEN OPENED AND USED. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7938304 ↗MalfunctionOct 5, 2018Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS INC. RECEIVED A COMPLAINT FROM AFFILIATE, (B)(6), STATING, NEEDLE PACKAGING HAS BREAK IN STERILE SEAL. NEEDLE HAS NOT BEEN OPENED AND USED. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEM AS RECORD (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7938302 ↗MalfunctionOct 5, 2018Unsealed Device Packaging; Unsealed Device Packaging
DEVICOR MEDICAL PRODUCTS INC. RECEIVED A COMPLAINT FROM AFFILIATE,(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 RECORD (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7938299 ↗MalfunctionJul 11, 2018Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED BY THE SALES REPRESENTATIVE, NEEDLE PACKING HAS VARYING DEGREES OF BREAKAGE LEAKAGE. NEEDLE HAS NOT OPENED AND USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7678514 ↗MalfunctionJun 22, 2018Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED BY THE (B)(4) AFFILIATE THAT NEEDLE PACKING HAS VARYING DEGREES OF BREAKAGE LEAKAGE. THESE NEEDLES ARE NOT OPENED AND NOT USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7629916 ↗MalfunctionJun 8, 2018Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED BY THE (B)(6) AFFILIATE THAT NEEDLES PACKING HAVE VARYING DEGREES OF BREAKAGE LEAKAGE. THESE NEEDLES ARE NOT OPENED AND USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7582629 ↗MalfunctionApr 30, 2018Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED BY THE (B)(4) AFFILIATE, THE PACKAGE WAS DAMAGED WITH LEAKAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7472126 ↗MalfunctionApr 24, 2018Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED BY THE (B)(6) AFFILIATE, THE PACKAGE OF WAS DAMAGED WITH LEAKAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7455776 ↗MalfunctionApr 5, 2018Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED BY THE (B)(6) AFFILIATE, THE PACKAGE OF WAS DAMAGED WITH LEAKAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7400666 ↗MalfunctionApr 2, 2018Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED BY THE CHINESE AFFILIATE, THE PACKAGE WAS DAMAGED WITH LEAKAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7391241 ↗MalfunctionApr 2, 2018Device Packaging Compromised; Device Packaging Compromised
IT WAS REPORTED BY THE CHINESE AFFILIATE, THE PACKAGE OF TWO PROBES WERE DAMAGED WITH LEAKAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7391240 ↗
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 · TerminatedMammotome EX Holster
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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