ENCOR® ECPMR0110GRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741086304), received between Oct 9, 2017 and Dec 19, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 reports).

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-1433-2020 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST A MAMMOGRAPHY GUIDED VACUUM ASSISTED BREAST BIOPSY PROCEDURE, A PIECE OF THE NEEDLE WAS ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT A PIECE OF NEEDLE FOUND INSIDE THE PATIENT BODY, AND IT WAS REMOVED THROUGH SURGERY. THE CURRENT STATUS OF THE PATIENT IS STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20974684 ↗
• MalfunctionJun 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A MRI GUIDED BREAST BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY HAD MECHANICAL PROBLEM. THE PROCEDURE WAS COMPLETED BY PRESSING VACUUM BUTTON TO FORCE STOP THE SAMPLING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600189 ↗
• MalfunctionAug 24, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD FOREIGN MATERIAL ON SAMPLE CUP. IT WAS FURTHER REPORTED THAT THE FOREIGN MATERIAL WAS REMOVED AND THE NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12357440 ↗
• MalfunctionJul 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL ECPMR0110G BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL FOUR MALFUNCTIONS DID NOT INVOLVE A PATIENTS AS THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10308248 ↗
• MalfunctionJan 22, 2020Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN MRI BREAST BIOPSY, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617068 ↗
• MalfunctionJan 17, 2020Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601742 ↗
• MalfunctionJan 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ECPMR0110G BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED FOREIGN MATERIAL PRESENT IN DEVICE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE 4 FOREIGN MATERIAL PRESENT IN DEVICES, 4 DID NOT INVOLVE PATIENTS. THERE WAS NO PROVIDED PATIENT INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 9588475 ↗
• MalfunctionOct 18, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ECPMR0110G BIOPSY INSTRUMENT ALLEGEDLY HAD A FOREIGN MATERIAL PRESENT IN THE DEVICE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. NONE OF THE TWO MALFUNCTIONS INVOLVED A PATIENT. THE AGE, WEIGHT, AND GENDER OF THE INTENDED PATIENTS WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9211458 ↗
• MalfunctionOct 9, 2017Break; Crack; Detachment of Device or Device Component; Break; Crack; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST BREAST BIOPSY UNDER MRI GUIDANCE, THE PROBE TROCAR TIP WAS ALLEGEDLY DETACHED FROM THE PROBE ONCE REMOVED FROM PATIENT. IT WAS FURTHER REPORTED THE TIP WAS NOT VISIBLE IN THE PATIENT UNDER IMAGING OR IN THE DEVICE PACKAGING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6933264 ↗