MILAGRO 219497Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705023165), received between Aug 7, 2018 and Dec 20, 2019 — classified as 2 malfunctions.

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

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING CLEANING PRIOR TO A MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION (MPFL) SURGICAL PROCEDURE, IT WAS FOUND THAT THEY COULD NOT GET THE GUIDEWIRE TO GO DOWN THEIR TAP 9MM-10MM MILAGRO ADVANCE DEVICE. THE SALES REP STATED IT APPEARED THAT THE DEVICE WAS CLOGGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9505533 ↗
• MalfunctionAug 7, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING POST TO AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, WHILE CLEANING THE INSIDE OF THE MILAGRO ADVANCE TAP, 9-10MM DEVICE, IT WAS OBSERVED THAT A PIECE OF THE BRUSH THAT WAS BEING USED TO CLEAN THE DEVICE BECAME STUCK WITHIN THE DEVICE. IT WAS REPORTED THAT WHEN THEY TRIED TO USE A GUIDEWIRE TO REMOVE THE PIECE OF BRUSH, THE GUIDEWIRE ALSO BECAME STUCK IN THE CANNULA OF THE TAP; AND WERE UNABLE TO REMOVE THE PIECES THAT WERE STUCK IN THE CANNULA OF THE TAP. IT WAS REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7757972 ↗