Mammotome revolveRecalls & reported problems across all models
Devicor Medical Products, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 12 models of Mammotome revolve by Devicor Medical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2018 and May 20, 2026 — classified as 10 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Failure to Obtain Sample” (18 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 revolve problems
Device problems
- Failure to Obtain Sample18
- Adverse Event Without Identified Device or Use Problem5
- Break2
- Fluid/Blood Leak2
- Material Fragmentation2
- Use of Device Problem2
- Connection Problem1
- Fail-Safe Did Not Operate1
Patient problems
- No Consequences Or Impact To Patient16
- Foreign Body In Patient6
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient4
- Hematoma2
- Electric Shock1
- Insufficient Information1
- Laceration(s)1
Mammotome revolve models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mammotome revolve MST1009Instrument, Biopsy8 reports
- Mammotome revolve MHUS08Instrument, Biopsy7 reports
- Mammotome revolve CA000399017Instrument, Biopsy6 reports
- Mammotome revolve MST0809Instrument, Biopsy5 reports
- Mammotome revolve MSTH1Instrument, Biopsy2 reports
- Mammotome revolve MST0812Instrument, Biopsy2 reports
- Mammotome revolve CA000399016Instrument, Biopsy2 reports
- Mammotome revolve CA000400003Instrument, Biopsy2 reports
- Mammotome revolve MST1012Instrument, Biopsy1 report
- Mammotome revolve MHUS10Instrument, Biopsy1 report
- Mammotome revolve DIRECT MARK GTINInstrument, Biopsy1 report
- Mammotome revolve CA000399007Instrument, Biopsy1 report
Recent Mammotome revolve adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Use of Device Problem
THE CUSTOMER REPORTED THAT THE APPLICATOR TIP SHEARED OFF IN THE BREAST AFTER THE MARKER WAS DEPLOYED. THE MAMMOMARK WAS PLACED DURING AN UPRIGHT ST PROCEDURE USING THE REVOLVE 10G PROBE. THE MARKER APPLICATOR TIP WAS VISIBLE OUTSIDE THE BIOPSY CAVITY IN THE POST-PROCEDURE IMAGE. THE MARKER APPLICATOR HAS BEEN DISCARDED.
Patient problems: Foreign Body In Patient
MAUDE report 25229170 ↗MalfunctionMar 6, 2026
FAULTY NEEDLE FOR BIOPSY NEEDLE WOULD NOT LOCK TO MACHINE NEEDLE HOLDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531718 ↗MalfunctionJan 7, 2026
WHEN SETTING UP NEEDLE, TONGUE AND GROOVE PIECE OF NEEDLE THAT ATTACHÉS TO OUR HOLSTER WAS CROOKED- WOULD NOT LINE UP WITH THE GROOVES TO SNAP INTO PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990430 ↗MalfunctionOct 31, 2025Leak/Splash
SET UP VACUUM ASSISTED NEEDLE FOR BIOPSY AND SALINE STARTED POURING OUT OF THE CONNECTED TUBE TO THE DEVICE. CHECKED SALINE SPIKE WAS NOT COMING FROM THERE, LOOKED LIKE A LEAK WHERE THE CONNECTER CONNECTS TO THE TUBE THAT SALINE RUNS THROUGH FROM THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 23435704 ↗MalfunctionJul 8, 2025Break; Connection Problem
UNABLE TO ATTACH STEREOTACTIC BIOPSY NEEDLE TO HOLDER TO PERFORM BIOPSY. GEAR ON NEEDLE APPEARS TO BE BROKEN/FAULTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435841 ↗MalfunctionMar 6, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING THE PROCEDURE THERE WAS AN INCIDENT OF FOREIGN BODY OF UNKNOWN ORIGIN IN RELATION TO THIS EQUIPMENT. THIS HAS RESULTED IN THIS EQUIPMENT BEING REMOVED FROM CLINICAL USE WITH IMMEDIATE EFFECT. CLIENT ATTENDED (B)(6)2025 FOR AN INITIAL 14G BIOPSY (HANDHELD BIOPSY DEVICE). AN ULTRACLIP MARKER WAS INSERTED DURING THIS PROCEDURE. THE PATHOLOGY RESULTS WERE B1 SO A FURTHER BIOPSY WAS ARRANGED FOR THIS MORNING. THIS REPEAT BIOPSY WAS PERFORMED WITH 10G NEEDLE ON THE MAMMOTOME VACUUM ASSISTED BIOPSY EQUIPMENT. 4 CORES WERE TAKEN AND UPON X-RAY EXAMINATION OF THESE A FOREIGN BODY WAS DISCOVERED WITHIN THE CORE. THIS HAS A CORKSCREW APPEARANCE AND IS NOT OF THE SAME SIZE OR SHAPE AS THE ULTRACLIP MARKER THAT WAS ALREADY IN SITU FROM PREVIOUS BIOPSY. THE ENTIRE MAMMOTOME NEEDLE SYSTEM WAS REMOVED FROM THE PATIENT AND A HYDROMARK CLIP WAS DEPLOYED (THIS IS A DIFFERENT SIZE AND SHAPE FROM ULTRACLIP TO ALLOW US TO DIFFERENTIATE BETWEEN THE 2 CLIPS). POST CLIP X-RAYS WERE TAKEN AND BOTH MARKERS ARE SEEN FULLY INTACT ON THE IMAGE. FROM ANALYSIS OF THE INITIAL X-RAYS, THERE WAS NO PREVIOUS METAL WORK IN THE CLIENT'S BREAST THAT COULD ACCOUNT FOR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21535769 ↗InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, METAL SHARDS WERE RETAINED WITHIN THE PATIENT AFTER COMPLETION OF THE BIOPSY. THE SHARDS ARE SEEN POST-MAKER PLACEMENT ON BOTH CRANIAL CAUDAL AND MEDIOLATERAL OBLIQUE POST-FILMS. IN THE MAMMOGRAPHY SLICES, THEY ARE SEEN ON THE 3RD AND 6TH SLICES. THE SHARDS ARE NOT IN THE BIOPSY CAVITY BUT ON THE SUPERFICIAL SKIN SURFACE. THE PROBLEM OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED MST1012.
Patient problems: Foreign Body In Patient
MAUDE report 21287177 ↗InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE THERE WAS INADEQUATE TISSUE OR NO TISSUE (NO ERROR CODE) AND CUTTER STALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. A SECOND INCISION WAS NEEDED TO COMPLETE THE PROCEDURE. NO MEDICAL TREATMENT. REPEATED CUT CAUSED WOUND. THE PROCEDURE TIME WAS LENGTHENED FOR ABOUT 15 MINUTES.
Patient problems: Laceration(s)
MAUDE report 18985814 ↗InjuryDec 27, 2023Unintended System Motion; Unintended System Motion
ACCORDING TO THE REPORTER, THE EVENT OCCURRED BEFORE BREAST BIOPSY PROCEDURE. BEFORE THE PIERCING, A 505 ERROR OCCURRED AND THE HOLSTER DISARMED. THE PROBE NEEDLE ADVANCED SLOWLY, AND NEEDLE WAS INSERTED INTO THE PATIENT'S BREAST. THE CUSTOMER REQUESTED AN INVESTIGATION INTO THIS EVENT. PROCEDURE WAS COMPLETED WITH DEVICE. THE CUSTOMER REPORTED NO PATIENT COMPLICATIONS.
Patient problems: Needle Stick/Puncture
MAUDE report 18397861 ↗InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE THERE WAS INADEQUATE TISSUE OR NO TISSUE (NO ERROR CODE) AND CUTTER STALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PROCEDURE TIME WAS LENGTHENED ONE HOUR AND THERE WAS REPEATED CUT THAT CAUSED WOUND. THE CUSTOMER REPORTED NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18012473 ↗MalfunctionMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE AFFILIATE REPORTED THAT AFTER IMPLANTING A HYDROMARK, THERE WAS A FOREIGN OBJECT OF A PIECE OF METAL OTHER THAN THE COIL. ACCORDING TO THE FACILITY, IT DID NOT APPEAR TO BE PLUNGER SHEARING, BUT IT DID SHOW AN OBJECT OF A PIECE OF METAL THAT WAS CLEARLY A DIFFERENT SHAPE THAN THE OPEN COIL. IMMEDIATELY THE FACILITY REMOVED THE FOREIGN OBJECT FROM THE PATIENT'S BODY.
Patient problems: Foreign Body In Patient
MAUDE report 16482158 ↗MalfunctionFeb 3, 2021Break; Break
IT WAS REPORTED BY SALES REP DURING PROCEDURE, FRAGMENTS LEFT IN BREAST AFTER FIRING AND BIOPSY. THIS INCIDENT HAS BEEN DOCUMENTED AS COMPLAINT # (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 11276874 ↗InjurySep 29, 2020Material Fragmentation; Material Fragmentation
IT WAS REPORTED VIA MEDWATCH VOLUNTARY EVENT REPORT THAT DURING A STEREOTACTIC LEFT BREAST BIOPSY PROCEDURE, A 12 CM, 10 GAUGE MAMMOTOME REVOLVE NEEDLE WAS INADVERTENTLY LOADED IN MAMMOTOME INSTEAD OF A 9 CM, 10 GAUGE NEEDLE. BIOPSY OF LEFT BREAST LESION WAS PERFORMED. POST BIOPSY IMAGES SHOWED A 4 MM V SHAPED RETAINED METALLIC FRAGMENT IN LEFT BREAST. INSPECTION OF THE NEEDLE SHOWED A DAMAGED CANNULA AT THE TIP. PATIENT WAS IMMEDIATELY REFERRED TO BREAST CLINIC AND SEEN BY BREAST SURGEON. PATIENT SCHEDULED FOR ELECTIVE SURGERY FOR REMOVAL OF BREAST LESION/CALCIFICATIONS AND RETAINED METALLIC FRAGMENT/FOREIGN BODY. THE ORIGINAL PACKAGING FOR THE PROBE IN QUESTION WAS NOT KEPT, NOR WAS THE PROBE. DEVICE WAS TRACED BACK TO (B)(6) HOSPITAL-(B)(6)(1383998) BASED OFF THE LOT NUMBER.
Patient problems: Foreign Body In Patient
MAUDE report 10601577 ↗InjuryApr 15, 2020Material Fragmentation; Material Fragmentation
IT WAS REPORTED BY SALES REP THAT AFTER SUCCESSFUL BIOPSY WITH ST MODALITY THERE WERE CURLY, STRING LIKE, OPAQUE, TINY, SHORT, THREADLIKE ARTIFACTS SEEN IN THE SPECIMEN FILM. THIS INCIDENT HAS BEEN RECORDED IN COMPLAINT #(B)(4). DEVICOR COULD NOT CONCLUDE THAT OUR DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT, DUE TO THE ALLEGATION OF AN ARTIFACT SEEN ON THE SPECIMEN FILM THIS HAS BEEN DETERMINED TO BE REPORTABLE PURSUANT TO 21 CFR 803. AS SUCH, WE ARE SUBMITTING THIS MEDWATCH REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 9965875 ↗MalfunctionApr 2, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT BEFORE PROCEDURE, IE DURING SET UP, THIER MSTH1 HOLSTER FIRED THE NEEDLE IMMEDIATELY AFTER ARMING THE HOLSTER. NO PATIENT COMPLICATIONS WERE REPORTED. THIS INCIDENT HAS BEEN RECORDED IN COMPLAINT #(B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9919074 ↗
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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