Azur CX Detachable 45-780516Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00810170018305), received between Sep 21, 2018 and May 11, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Physical Resistance/Sticking; Premature Separation

  AS REPORTED, THE AZUR CX 18 DETACHABLE COIL FELT SMOOTH WHEN PUSHED UP TO TIP OF THE PROGREAT MICRO CATHETER BUT COULD NOT PUSH IT FURTHER DESPITE USING A NEW PROGREAT MICRO CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED: TIP OF THE AZUR CX 18 DETACHABLE COIL WENT ALL THE WAY TO THE TIP OF THE PROGREAT MICRO CATHETER HOWEVER, THIS DETACHED FROM DELIVERY WIRE AND THE USER WAS ABLE TO FLUSH IT INTO THE ANEURYSM WITH NO ISSUE. THERE WAS A TIGHT CO-ILIAC TRUNK STENOSIS TO GET THROUGH BEFORE GOING INTO THE GDA. IT WAS INDICATED THAT THIS MAY HAVE CONTRIBUTED. THERE WAS NO ISSUE FOR THE PATIENT AND THE COIL REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143905 ↗
• MalfunctionJun 24, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A HEMORRHOID EMBOLIZATION PROCEDURE, A EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY WHEN IT ENCOUNTERED RESISTANCE. IT WAS REPORTED THAT THIS WAS PROBABLY DUE TO OVERSIZING, AND OCCURRED WHEN COILING IN A 90° ARTERY ANGLE. AFTER THE PREMATURE RELEASE, THE STILL MANAGED TO PUSH OUT THE REST OF THE COIL, WHICH REMAINED IN THE CATHETER, WITH HIS GT GUIDE, WITHOUT ANY CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325118 ↗
• MalfunctionJan 24, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A GASTRODUODENAL (GDA) EMBOLIZATION COILING, THE PHYSICIAN ATTEMPTED TO IMPLANT THE COIL; HOWEVER, THE COIL BROKE FROM THE PUSHER WIRE AS THE PHYSICIAN WAS RETRACTING THE COIL INTO THE MICROCATHETER. THE COIL WAS CONTAINED WITHIN THE MICROCATHETER, AND THE PHYSICIAN WAS ABLE TO SAFELY REMOVE THE COIL IN ITS ENTIRETY WITHIN THE MICROCATHETER. THE GDA WAS SUCCESSFULLY EMBOLIZED, AND THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568330 ↗
• MalfunctionDec 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT BECAME DETACHED UNEXPECTEDLY AND WAS REMOVED WITHOUT INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085525 ↗
• MalfunctionDec 10, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT BECAME STUCK IN THE MICROCATHETER AND DETACHED WITHIN IT. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981342 ↗
• MalfunctionOct 26, 2021Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF A PANCREATIC PSEUDO ANEURYSM, THE PHYSICIAN WAS UNABLE TO GET AN EMBOLIZATION COIL IMPLANT TO FORM TO THEIR LIKING AND DECIDED TO REMOVE THE IMPLANT. UPON ATTEMPTED REMOVAL, THE IMPLANT DETACHED UNEXPECTEDLY AND REMAINED ENTIRELY WITHIN THE TREATMENT SITE. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698518 ↗
• InjuryMar 20, 2019Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component; Difficult or Delayed Positioning; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER REPEATED ATTEMPTS TO REPOSITION AN EMBOLIZATION COIL IN THE GASTRODUODENAL ARTERY, THE COIL DETACHED INSIDE THE MICROCATHETER. THE DETACHED COIL WAS REMOVED IN ITS ENTIRETY WITH A SNARE DEVICE WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438086 ↗
• MalfunctionOct 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A GASTRODUODENAL ARTERY ANEURYSM, THE EMBOLIZATION COIL DETACHED IN THE MICROCATHETER. THE COIL HAD NOT ENTERED THE PATIENT AND WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8011167 ↗
• InjurySep 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING REPOSITIONING OF AN EMBOLIZATION COIL IN A RUPTURED ANEURYSM, RESISTANCE WAS ENCOUNTERED AND THEN THE COIL DETACHED IN THE VESSEL. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED; HOWEVER, THE COIL WAS POSITIONED SUBOPTIMALLY, A LITTLE LOWER THAN EXPECTED, WHICH OCCLUDED A RELATIVELY LARGE SPLENIC VESSEL. AS A RESULT, THE PATIENT RECEIVED APPROPRIATE VACCINES DUE TO THE POSSIBLE RISK OF SPLENIC INFARCTION AND POTENTIAL FOR ASPLENIA. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT, AND THE PATIENT IS CURRENTLY REPORTED TO BE FEELING WELL.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 7900189 ↗