ENCOR® ECMRINTLOCRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741086229), received between Nov 28, 2018 and Sep 15, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Break; Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material; Break; Improper or Incorrect Procedure or Method; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE VISILOC INTRODUCER SET. PRIOR TO THE PROCEDURE, IT WAS NOTED THE CONTRAST MARKER OF THE INTRODUCER SET HAD BLACK SPOTS WITHIN THE OBSTRUCTOR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048626 ↗
• MalfunctionMay 27, 2025Break; Device Contamination with Chemical or Other Material; Insufficient Device Problem Information; Break; Device Contamination with Chemical or Other Material; Insufficient Device Problem Information

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE VISILOC INTRODUCER SET. PRIOR TO THE PROCEDURE, IT WAS NOTED THE CONTRAST MARKER OF THE INTRODUCER SET HAD BLACK SPOTS WITHIN THE OBSTRUCTOR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088922 ↗
• MalfunctionApr 13, 2024Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, INK WAS ALLEGEDLY NOTICED WHICH MADE IT APPEARED CONTAMINATED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102513 ↗
• MalfunctionApr 27, 2022Use of Device Problem; Device Contamination with Chemical or Other Material; Use of Device Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14216517 ↗
• MalfunctionMay 28, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PRODUCT RECEIVED WAS SHORT DATED AND CANNOT BE USED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899540 ↗
• MalfunctionMay 28, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PRODUCT RECEIVED WAS SHORT DATED AND CANNOT BE USED . THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899519 ↗
• MalfunctionNov 28, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS ALLEGEDLY A 7 GAUGE COAXIAL INTRODUCER PACKAGED IN A BOX MARKED FOR A 10 GAUGE PRODUCT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8113460 ↗