ENCOR® ECPMR0110GBTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741086311), received between Nov 30, 2024 and Nov 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 3, 2020Terminated

   Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

   Z-1434-2020 · Root cause: Component change control · FDA record ↗

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.

• MalfunctionNov 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN MRI GUIDED VACUUM ASSISTED BREAST BIOPSY THROUGH MASS DENSITY, THE NEEDLE OF THE DEVICE ALLEGEDLY BROKE OFF. IT WAS FURTHER REPORTED THAT THE HALF OF THE NEEDLE LODGED IN THE VISILOC AND THE OTHER HALF REMAINED IN THE PATIENT. REPORTEDLY THE BROKE FRAGMENTS WERE REMOVED USING CLIPS AND CONFIRMED NO METAL WAS LEFT BEHIND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20813619 ↗