MILAGRO 219496Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705023158), received between Sep 20, 2021 and Sep 4, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Degraded” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE THAT THE MILAGRO DEVICE TAP 7&8 SIZE WAS BENT AND HAD BEEN THROWN OUT. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133308 ↗
• MalfunctionSep 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TAP 7MM-8MM - MILAGRO ADVANCE DEVICE HAD SOMETHING IN THE CANNULA; AND THEY WERE UNABLE TO CLEAN IT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701545 ↗
• MalfunctionJul 13, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE DEVICE WAS NOT CATCHING THE BONE. THE PROCEDURE WAS COMPLETE WITH THE SAME DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006856 ↗
• MalfunctionSep 20, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE TAP OF THREE OF THE TAP 7MM-8MM - MILAGRO ADVANCE WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500452 ↗
• MalfunctionSep 20, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE TAP OF THREE OF THE TAP 7MM-8MM - MILAGRO ADVANCE WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500400 ↗
• MalfunctionSep 20, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE TAP OF THREE OF THE TAP 7MM-8MM - MILAGRO ADVANCE WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500287 ↗