Azur Detachable Framing Coil 45-681434Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810170017803), received between Sep 27, 2018 and Oct 14, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 18, 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.

• InjuryOct 14, 2024Migration; Separation Problem; Difficult or Delayed Separation; Migration; Separation Problem; Difficult or Delayed Separation

  AS REPORTED, FAULTY RELEASE SYSTEM. REMOVAL OF THE COIL BY LASSO. NO CONSEQUENCES FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447494 ↗
• InjuryFeb 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A COILING OF A BYPASS ANEURYSM, AFTER PLACING THE COIL. THE COIL WAS IN THE WRONG LUMEN AND UNINTENTIONALLY DETACHED WITHOUT THE USE OF THE CONTROLLER. THE COIL WAS RETRIEVED WITH A SNARE DERIVE AND HAS BEEN REMOVED COMPLETELY. THE PROCEDURE CONTINUED WITH OTHER COILS THAT WERE PLACED SUCCESSFULLY. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT AND NO SIGNIFICANT DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350733 ↗
• MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE ADVANCING THE COIL OUT OF THE MICROCATHETER, WHICH WAS IN POSITION, THE COIL ONLY ADVANCED A FEW INCHES AND THEN DETACHED AT ITS DETACHMENT POINT. THE COIL WAS ADVANCED INTO THE TARGET SITE WITH THE GLIDEWIRE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8756056 ↗
• InjurySep 27, 2018Migration; Migration

  IT WAS REPORTED THAT NINE (9) COILS WERE IMPLANTED IN AN ARTERIOVENOUS (AV) FISTULA OFF THE RIGHT ILIAC ARTERY IN (B)(6) 2018. APPROXIMATELY THREE (3) MONTHS LATER IN (B)(6) THE PATIENT HAD SYMPTOMATIC COMPLAINTS IN HER PELVIS AGAIN. ANGIOGRAPHIC EXAMINATION REVEALED THE COIL PACK WAS NO LONGER IN THE AREA OF THE AV FISTULA, AND HAD MIGRATED TO THE PATIENT'S LUNG. ATTEMPTS WERE MADE TO RETRIEVE THE COIL PACK OVER A PERIOD OF 1.5 HOURS; HOWEVER, THEY WERE UNSUCCESSFUL. THE PATIENT HAS HAD NO SYMPTOMS OF COMPLICATIONS IN THE RESPIRATORY SYSTEM. THE PATIENT HAS BEEN REFERRED TO A CT SURGEON. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916756 ↗
• InjurySep 27, 2018Migration; Migration

  IT WAS REPORTED THAT NINE (9) COILS WERE IMPLANTED IN AN ARTERIOVENOUS (AV) FISTULA OFF THE RIGHT ILIAC ARTERY IN (B)(6) 2018. APPROXIMATELY THREE (3) MONTHS LATER IN (B)(6) THE PATIENT HAD SYMPTOMATIC COMPLAINTS IN HER PELVIS AGAIN. ANGIOGRAPHIC EXAMINATION REVEALED THE COIL PACK WAS NO LONGER IN THE AREA OF THE AV FISTULA, AND HAD MIGRATED TO THE PATIENT'S LUNG. ATTEMPTS WERE MADE TO RETRIEVE THE COIL PACK OVER A PERIOD OF 1.5 HOURS; HOWEVER, THEY WERE UNSUCCESSFUL. THE PATIENT HAS HAD NO SYMPTOMS OF COMPLICATIONS IN THE RESPIRATORY SYSTEM. THE PATIENT HAS BEEN REFERRED TO A CT SURGEON. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916751 ↗
• InjurySep 27, 2018Migration; Migration

  IT WAS REPORTED THAT NINE (9) COILS WERE IMPLANTED IN AN ARTERIOVENOUS (AV) FISTULA OFF THE RIGHT ILIAC ARTERY IN (B)(6) 2018. APPROXIMATELY THREE (3) MONTHS LATER IN (B)(6) THE PATIENT HAD SYMPTOMATIC COMPLAINTS IN HER PELVIS AGAIN. ANGIOGRAPHIC EXAMINATION REVEALED THE COIL PACK WAS NO LONGER IN THE AREA OF THE AV FISTULA, AND HAD MIGRATED TO THE PATIENT'S LUNG. ATTEMPTS WERE MADE TO RETRIEVE THE COIL PACK OVER A PERIOD OF 1.5 HOURS; HOWEVER, THEY WERE UNSUCCESSFUL. THE PATIENT HAS HAD NO SYMPTOMS OF COMPLICATIONS IN THE RESPIRATORY SYSTEM. THE PATIENT HAS BEEN REFERRED TO A CT SURGEON. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916749 ↗