Azur Detachable Framing Coil 45-651434Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810170016127), received between Oct 27, 2017 and Jul 9, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJul 9, 2024Separation Problem; Separation Problem

  AS REPORTED: DURING A PROXIMAL SPLENIC EMBO, DR. HAD A 30CM SHEATH IN THE AORTA AND A 100CM 4FR ANGLED CATHETER IN THE SPLENIC ARTERY. THE ARTERY MEASURED 8-9MM IN DIAMETER. THE FIRST COIL USED WAS AN 35 14X34 FRAMING COIL. DR. ADVANCED THE COIL TO THE TIP OF THE CATHETER AND IT BECAME STUCK. WITHIN A FEW SECONDS OF MANIPULATING THE COIL, DR. STATED THAT HE FELT LIKE THE COIL BROKE FREE. HE REMOVED WHAT WAS LEFT OF THE PUSHER WIRE AND INJECTED SALINE INTO THE CATHETER TO SHOOT THE COIL OUT INTO THE VESSEL. THE COIL LANDED WHERE HE WANTED, HOWEVER, A LONG PORTION OF THE PUSHER WIRE WAS STILL ATTACHED TO THE COIL. THE WIRE SNAPPED IN HALF, IT WASN'T THE COIL DETACHING LIKE HE SUSPECTED. THE WIRE PROLAPSED INTO A COLLATERAL VESSEL AND TRACKED ALL THE WAY BACK TO THE ORIGIN OF THE SPLENIC ARTERY. IT WAS NOTICED THAT THE CATHETER KINKED AT THE PROXIMAL PORTION OF THE SPLENIC ARTERY. FROM THERE, HE DECIDED TO CONTINUE THE PROCEDURE AND PUT A 45CM SHEATH UP INTO THE SPLENIC ARTERY ALONG WITH A NEW 4FR 100CM ANGLED CATHETER AND CONTINUED TO DEPLOY SIX 035 AZUR CX COILS WITHOUT INCIDENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707223 ↗
• MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PLEASE SEE H10 FOR DEVICE INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550757 ↗
• MalfunctionJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A PELVIC CONGESTION CASE, A COMBINATION OF MULTIPLE EMBOLIZATION COIL IMPLANTS WAS USED WHEN THE FRAMING COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL, TOGETHER WITH THE CATHETER, WERE REMOVED AND REPLACED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063042 ↗
• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, AN EMBOLIZATION COIL IMPLANT UNEXPECTEDLY DETACHED IN THE MICROCATHETER. THE COIL, TOGETHER WITH THE CATHETER, WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942552 ↗
• MalfunctionDec 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION IMPLANT COIL UNEXPECTEDLY DETACHED IN A MICROCATHETER DURING TREATMENT OF AN ENDOLEAK IN THE INTERNAL ILIAC ARTERY. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508080 ↗
• MalfunctionOct 27, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE TREATMENT OF A DISTAL SPLENIC ANEURYSM, THE COIL GOT STUCK AT THE TIP OF THE MICROCATHETER. WHEN THE COIL WAS PUSHED HARDER, THE PUSHER WIRE SEPARATED FROM THE COIL AND THE COIL THEN DETACHED IN THE MICROCATHETER. AN ATTEMPT WAS MADE TO PUSH THE COIL INTO THE ANEURYSM WITH A GUIDEWIRE; HOWEVER, THE COIL REMAINED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE WITHDRAWN TOGETHER WITH THE MICROCATHETER, AND REMOVED IN THEIR ENTIRETY. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985631 ↗