Mammotome revolve DIRECT MARK GTINRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841911101895), received between May 7, 2019 and May 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K152989); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2019Use of Device Problem; Use of Device Problem

  DEVICOR MEDICAL PRODUCTS INC. RECEIVED A REPORT FROM USER FACILITY STATING, "HOLSTER STARTED PRODUCING SMOKEY SMELL DURING A BIOPSY. THEY TESTED IT OUT AGAIN AND IT SMELLED LIKE SMOKE. THE TECH THEN PICKED UP THE HOLSTER AND IT SHOCKED HER SEVERAL TIMES". THE TECHNICIAN REPORTED PAIN AND NUMBNESS IN HER ARM FOR THE DURATION OF APPROXIMATELY ONE HOUR FOLLOWING THE INCIDENT. THE TECHNICIAN DECLINED MEDICAL INTERVENTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL INFORMATION REGARDING THE REPORTED SHOCKS. THIS HAS BEEN DOCUMENTED IN OUR COMPLAINT SYSTEMS AS RECORD # (B)(4).

  Patient problems: Electric Shock

  MAUDE report 8588927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152989. One submission often covers many models, so check the product and lot details in each record.

• Z-1512-2017 · Feb 28, 2017 · Terminated
  Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance