Azur CX Detachable 45-750824Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00812636021065), received between Jul 20, 2016 and Jun 30, 2026 — classified as 27 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (43 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MICROVENTION: SUCCESSFUL COIL EMBOLIZATION OF OVARIAN VEIN UTILIZING QTY 13- 0.035" CX COILS ON FRIDAY (B)(6) 2026. POST PROCEDURE, PATIENT PRESENTED WITH DIFFUSE RASH ON MONDAY (B)(6) 2026 AND PHYSICIAN CLAIMED THAT THE RASH WAS AN ALLERGIC REACTION TO THE COILS. DOCTOR PRESCRIBED MEDROL DOSEPACK ON MONDAY (B)(6) 2026. THE PATIENT CLAIMED NO METAL ALLERGY. THE PATIENT ALSO HAD A VENOGRAM A WEEK PRIOR TO COIL EMBOLIZATION AND DID NOT HAVE A REACTION POST-PROCEDURE. NO OTHER EMBOLICS USED, NO GEL FOAM, NO SCLEROTHERAPY. QUANTITY OF 13 TOTAL 0.035" CX COILS USED. DEVICE REMAINS IMPLANTED. NO OTHER INCIDENT INFORMATION WAS PROVIDED. AS THE RELATIONSHIP OF THE DEVICE TO THE REPORTED CONDITION COULD NOT DEFINITIVELY BE RULED OUT, THIS EVENT IS BEING REPORTED.

  Patient problems: Rash

  MAUDE report 25667988 ↗
• MalfunctionJun 17, 2026Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS BEING USED IN A GDA EMBOLIZATION PROCEDURE. REPORTEDLY DURING ADVANCING THE COIL IN THE MICROCATHETER, THE COIL PREMATURELY DETACHED PRIOR TO PLACEMENT IN INTENDED SITE. IT WAS UNKNOWN WHETHER THE COILS DETACHED AT THE HUB OR MORE DISTAL IN THE MICROCATHETER. THE SAME NON-TERUMO NEURO CATHETER WAS USED WITH ALL THREE COILS. THE COIL AND CATHETER WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING WELL AT THE END OF THE PROCEDURE. THIS IS EVENT REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540864 ↗
• InjuryJun 5, 2026Migration or Expulsion of Device

  THE COMPANY RECENTLY RECEIVED A LEGAL CLAIM LETTER DATED APRIL 28, 2026, REPORTING, FOR THE FIRST TIME, POST-OPERATIVE INJURIES THAT OCCURRED 2 YEARS AFTER ON (B)(6) 2023 EMBOLIZATION PROCEDURE. AS REPORTED, A FEMALE PATIENT UNDERWENT EMBOLIZATION FOR PELVIC VENOUS INSUFFICIENCY USING SEVERAL AZUR® CX DETACHABLE COILS MANUFACTURED BY TERUMO MEDICAL/MICROVENTION. TWO YEARS AFTER THE COILS WERE IMPLANTED IN THE LEFT OVARIAN VEIN, IT WAS REPORTED THAT ONE OR MORE MIGRATED TO THE PULMONARY CIRCULATION, SPECIFICALLY LODGING IN THE LEFT LOWER LOBE OF THE LUNG. THIS MIGRATION LED TO PULMONARY SYMPTOMS AND COMPLICATIONS, REQUIRING THE PATIENT TO BE HOSPITALIZED AND UNDERGO BOTH ANTICOAGULATION THERAPY AND AT LEAST ONE SURGICAL OR ENDOVASCULAR INTERVENTION ON (B)(6) 2025. THE OUTCOME IS CONSIDERED A SERIOUS INJURY, WITH SIGNIFICANT MEDICAL INTERVENTION AND ONGOING HEALTH IMPACTS. THE DEVICES INVOLVED ARE MULTIPLE AZUR® CX DETACHABLE COILS (VARIOUS SIZES AND CATALOG NUMBERS), WHICH ARE DESIGNED FOR VASCULAR OCCLUSION PROCEDURES. THE ISSUE REPORTED IS MIGRATION OF THE COIL(S) AFTER PROPER IMPLANTATION¿THERE IS NO ALLEGATION OF DEVICE BREAKAGE OR DETACHMENT FAILURE BEFORE DEPLOYMENT. THE PRIMA

  Patient problems: Pulmonary Embolism

  MAUDE report 25411333 ↗
• MalfunctionMay 28, 2026Component Missing

  IT WAS REPORTED THAT BY THE PHYSICIAN THAT WHILE PERFORMING A VARICOCELE EMBOLIZATION, SHE CHOSE AN AZUR COIL IMPLANT, PREPPED NORMALLY AND SHE INTRODUCED COIL CASING TO HUB OF CATHETER AND STARTED ADVANCING THE PUSHER WIRE. THE PHYSICIAN REMOVED THE CASING, AND SHE HIT THE FLUORO PEDAL AND CONTINUED TO ADVANCE THE COIL. SHE THEN NOTICED THAT THE COIL PACK STARTED TO MOVE BUT SHE DIDN'T SEE ANY COIL. SHE THEN PULLED BACK AND NOTICED THAT THERE WAS NO COIL ON THE END OF THE PUSHER WIRE. SHE SPENDS A FAIR BIT OF TIME ENSURING THE COIL HAD NOT DETACHED ANYWHERE IN HER SYSTEM. IT WAS THEN ASSUMED THAT NO COIL WAS EVER PRESENT ON THE PUSHER WIRE. THE PATIENT OUTCOME IS CURRENTLY UNKNOWN, AND TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321231 ↗
• MalfunctionApr 23, 2026Premature Separation

  AS REPORTED: DURING FISTULA EMBO, COIL GOT STUCK INSIDE CATHETER AND THEN ''BROKE OFF'' INSIDE THE CATHETER. WHEN THE COIL "BROKE OFF", THE CATHETER WAS INSIDE THE PATIENT. THEY REMOVED THE CATHETER COMPLETELY WITH THE COIL IN IT. THE CASE CONTINUED, A NEW CATHETER WAS INTRODUCED AND REMAINING COILS WERE USED. IMMEDIATELY POST OP THE PATIENT WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974428 ↗
• MalfunctionApr 13, 2026Premature Separation

  AS REPORTED, DURING A VISCERAL EMBOLIZATION PROCEDURE, THE AZUR CX 35 COIL DID NOT DEPLOY PROPERLY. THE IMPLANT DETACHED WHILE INSIDE THE PATIENT BODY IN THE CATHETER BUT WAS REMOVED SAFELY BY THE SURGEON. AFTER THE COIL WAS REMOVED, NO OTHER COILS WERE ATTEMPTED TO BE PLACED. THE SURGEON DECIDED TO EMBOLIZE USING A PLUG INSTEAD. THE PROCEDURE AND PATIENT OUTCOME WERE SUCCESSFUL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867391 ↗
• InjuryApr 3, 2026Unraveled Material; Premature Separation

  AS REPORTED BY THE PHYSICIAN AND LEAD TECH, THE PATIENT CAME FROM THE EMERGENCY DEPARTMENT FOR A LARGE UNCONTROLLED LEG HEMATOMA. THE PATIENT WAS AROUND LATE 80¿S/EARLY 90¿S IN AGE. THE PATIENT EXHIBITED INSTABILITY WITH REGARDS TO MENTAL FACULTIES (HIGH ANXIETY AND LACK OF LUCIDITY) WHICH MAY HAVE CONTRIBUTED TO ELEVATED AND UNSTABLE CARDIAC LEVELS DURING THE PROCEDURE. THEY ALSO CONFIRMED THAT NEITHER BELIEVED THE PATIENT'S BRADYCARDIA AND ASYSTOLE INTRA-PROCEDURE WERE CAUSED BY THE SELF-DEPLOYED COIL. THEY MENTIONED THAT THE PATIENT WAS NOT INTUBATED OR UNDER GENERAL ANESTHESIA. THE PHYSICIAN EXPRESSED SELF-REFLECTION THAT HAVING THE PATIENT ONLY SEDATED WAS NOT IDEAL BECAUSE THE PATIENT MOVED A LOT DURING THE PROCEDURE AND THAT COULD HAVE CONTRIBUTED TO THE REPORTED CARDIAC ISSUES WITHIN THE CASE. IT WAS REPORTED BY THE PHYSICIAN THAT THE CASE WAS A RLE ANGIO WITH POSSIBLE INTERVENTION TO CONTROL THE LEG HEMATOMA DEVELOPING ON THE THIGH. TO ACCESS THE HEMATOMA, THE PHYSICIAN ENGAGED THE RIGHT PROFUNDA AND FEEDING COLLATERAL ARTERY. THE PHYSICIAN THEN UTILIZED 035 CX COILS BECAUSE THE PHYSICIAN WANTED TO STICK WITH THE 5F BASE CATHETER. A KUMPE WAS USED TO ACCESS THE FEEDING VES

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24783012 ↗
• MalfunctionMar 26, 2026Premature Separation

  AS REPORTED: THE AZUR COIL PREMATURELY DEPLOYED IN THE ANGIOGRAPHIC CATHETER INSTEAD OF IN THE PATIENT TARGET EMBOLIZATION ZONE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702545 ↗
• InjuryMar 18, 2026Premature Separation

  AS REPORTED, THE PHYSICIAN WAS PERFORMING A DE-CLOT ON A FISTULA ON THE LEFT ARM. ACCESS SITE WAS WITH A 7F SHEATH IN THE BRACHIAL ARTERY. AFTER PLACING ONE .035 AZUR COIL, HE THEN ATTEMPTED A SECOND COIL WHICH BROKE OFF IN THE 5F RIM CATHETER. HE TRIED TO PUSH IT OUT BUT IT WOULD NOT MOVE. HE THEN ABANDONED THE CASE AND REMOVED EVERYTHING. WHILE REMOVING THE CATHETER, THE SHEATH BACKED OUT OF THE BRACHIAL ARTERY AND PATIENT BEGAN BLEEDING FROM THE SITE. THE PHYSICIAN WAS ABLE TO RE-ACCESS THE SITE AND PLACED A COVERED STENT TO STOP THE BLEEDING. PATIENT IS DOING FINE. NO ADVERSE EVENTS. ADDITIONAL INFORMATION INDICATED: NO FURTHER TREATMENT IS NEEDED TO TREAT THE FISTULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627039 ↗
• InjuryFeb 9, 2026Unraveled Material; Premature Separation

  IT WAS REPORTED THAT THE RIGHT FEMORAL ACCESS TO THE LEFT INTERNAL ILIAC EMBOLIZATION TARGET 100CM 4FR STRAIGHT GLIDECATH WAS USED WITH GUIDESHEATH SUPPORT TO CANNULATE THE INTERNAL ILIAC. AN AZUR 8X24 35CX COIL WAS PREPPED PROPERLY AND INTRODUCED AND TRACKED TO THE TARGET. APPROXIMATELY A THIRD OF THE COIL WAS DEPLOYED PAST THE DELIVERY CATHETER. WHEN THE OPERATOR ATTEMPTED TO PULL BACK ON THE PUSHER WIRE AND THE COIL DID NOT MOVE. IT WAS DETERMINED THAT THE COIL HAD DETACHED ON ITS OWN. UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE COIL WAS SOMEHOW STILL ATTACHED TO SOMETHING. THEY INSPECTED THE PUSHER WIRE ON THE FIELD AND REALIZED IT SEPARATED MORE PROXIMAL FROM WHERE THE COIL WAS ACTUALLY DETACHED. IT APPEARED AS IF THE PUSHER WIRE PULLED APART AND WAS NOW A SPIRAL STRING. THE OPERATOR WAS ABLE TO REMOVE THE DELIVERY CATHETER AND GRAB THE PUSHER WIRE WITH STATS AND REMOVED THE COIL. THERE WAS NO PATIENT INJURY. THE OPERATOR SUCCESSFULLY DEPLOYED THE FOLLOWING CX35 8X12 6X17 COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300144 ↗
• MalfunctionFeb 3, 2026Premature Separation

  IT WAS REPORTED: DURING AN ILIAC EMBOLIZATION, WHEN USING THE DETACHMENT CONTROLLER TO DETACH THE COIL, THE GREEN LIGHTS FLASHED BUT IT WOULDN¿T DETACH THE COIL. THE TECH ATTEMPTED SEVERAL TIMES, AND IT WOULDN¿T DETACH THE COIL. WHILE RETRACTING THE COIL BACK INTO THE CATHETER, THE COIL DEPLOYED IN THE CATHETER. A SECOND COIL OF THE SAME SIZE WAS OPENED FOR THE CASE. A NEW COIL WAS PLACED, AND A NEW AZUR DETACHMENT SYSTEM WAS USED. BOTH WERE SUCCESSFULLY USED WITH NO MORE ISSUES. THERE WAS NO PATIENT IMPACT OR INJURY. NO OTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254668 ↗
• MalfunctionJan 5, 2026Premature Separation

  IT WAS REPORTED THAT AFTER DEPLOYING FOUR COILS WITH SUCCESS INTO THE INTERNAL ILIAC VEIN, AND THE REMOVAL OF ONE COIL DUE TO COIL ELONGATION, ANOTHER COIL WAS ADVANCED INTO THE COIL MASS. WHILE TRYING TO REPOSITION THE PROXIMAL END OF THE COIL, THE COIL'S FILAR ELONGATED AND THE COIL DETACHED FROM THE PUSHER WIRE. WE THEN FLUSHED THE COIL OUT OF THE GLIDECATH WITH SALINE AND A SCLEROSING AGENT WAS USED TO SUCCESSFULLY FINISH THE PROCEDURE. THE PATIENT IS OK WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967338 ↗
• MalfunctionDec 29, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS COILING A HYPOGASTRIC ARTERY PRE-AAA. WHEN THE PHYSICIAN WAS DELIVERING COIL THROUGH 100CM LENGTH 4FR ANGLED GLIDECATH, THE COIL MET RESISTANCE AND BECAME DETACHED. THE AZUR PUSHER WIRE WAS REMOVED. THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER AND THE COIL AS A SYSTEM. THE PROCEDURE WAS COMPLETED USING THREE 6X17 AZUR 035 CX. THE PATIENT OUTCOME WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23911173 ↗
• MalfunctionNov 21, 2025Premature Separation; Premature Separation

  AS REPORTED: TIPS PROCEDURE WITH VEIN EMBOLIZATION. GUIDING SHEATH AND 5FR X 100CM ANGLED CATHETER WERE IN POSITION, COIL PREPPED AND CATHETER FLUSHED. ADVANCED COIL BUT IT WOULD NOT REACH THE TIP OF CATHETER. ATTEMPTED TO WITHDRAW COIL AND FELT IT DETACH. UPON INSPECTION, NOTED THAT COIL HAD STRETCHED WITHIN CATHETER. CATHETER WAS REMOVED WITH COIL IN IT. NEW CATHETER ADVANCED AND PROCEDURE CONTINUED AND COMPLETED WITHOUT ISSUE. THE COIL DETACHED AND STRETCHED INSIDE THE MICROCATHETER. THE PUSHER WIRE WAS REMOVED PRIOR TO THE CATHETER WITH THE COIL STILL INSIDE BEING REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615262 ↗
• MalfunctionNov 3, 2025Stretched; Unraveled Material; Stretched; Unraveled Material

  IT WAS REPORTED THAT "ACCOUNT STATED PRODUCT UNRAVELED". ADDITIONAL INFORMATION: ACCORDING TO THE PHYSICIAN, REMOVED IT IMMEDIATELY BY PULLING IT BACK OUT OF THE CATHETER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447271 ↗
• InjuryOct 15, 2025Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL WAS USED DURING AN INTERNAL ILIAC ARTERY PROCEDURE WITH THE USE OF A DESTINATION GUIDING SHEATH AND A 5FR CATHETER, UP-AND-OVER ACCESS. THE FIRST TWO AZUR CX35 COILS WERE DELIVERED WITHOUT ISSUES TO THE TARGET LOCATION. THE PHYSICIAN PREPPED AND DELIVERED THIRD 8X24 COIL, BUT IT DID NOT LAND WHERE DESIRED. THE PHYSICIAN PULLED BACK THE COIL AND READVANCED. PULLED BACK AND TRIED AGAIN AND MENTIONED THAT THE COIL LOOKED LIKE IT STRETCHED AND THEN DETACHED. MULTIPLE WIRES USED TO TRY AND PUSH COIL INTO POSITION WITHOUT SUCCESS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT AFTER THE COIL DID NOT LAND WHERE DESIRED ON SECOND ATTEMPT, PHYSICIAN PULLED THE COIL BACK AGAIN AND TRIED AGAIN TO READVANCE BUT WAS MEETING RESISTANCE AND NOTED THAT THE COIL APPEARS TO HAVE STRETCHED AND THEN DETACHED AS HE WAS TRYING TO WITHDRAW IT. THE CATHETER AND THE COIL WERE REMOVED. THE PROCEDURE WAS SUCCESSFUL, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297632 ↗
• MalfunctionAug 27, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PRE-EVAR CASE, THE COIL DETACHED IN THE CATHETER AS THEY WERE TRACKING IT FORWARD. THEY PULLED THE CATHETER OUT AND USED SYRINGE TO PULL IT OUT, THEN GAINED ACCESS AGAIN. THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910174 ↗
• InjuryAug 14, 2025Stretched; Premature Separation; Stretched; Premature Separation

  IT WAS REPORTED THAT WHEN THE COIL WAS BEING POSITIONED IN THE VESSEL DURING A CORONARY FISTULA EMBOLIZATION, THE COIL PREMATURELY DETACHED. A SECOND ACCESS POINT WAS MADE IN THE RIGHT FEMORAL ARTERY TO GO UP AND CAPTURE THE COIL AFTER IT HAD DETACHED ON ITS OWN. HOWEVER, THE COIL BEGAN TO UNRAVEL WHEN BEING SNARED. APPROXIMATELY, THIRTY TO FORTY-FIVE MINUTES WERE NEEDED TO SUCCESSFULLY SNARE THE COIL. THE CASE PROCEEDED AFTER THE ENTIRE COIL WAS REMOVED FROM THE PATIENT. THE CORONARY FISTULA WAS SHUT DOWN USING A COUPLE MORE COILS, AND THEY DETACHED NORMALLY. OVERALL, THE CASE WAS SUCCESSFUL. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809806 ↗
• InjuryJul 21, 2025Inadequacy of Device Shape and/or Size; Stretched; Inadequacy of Device Shape and/or Size; Stretched

  AS REPORTED FROM THE HOSPITAL TO THE SALES REP, CASE WAS GI BLEED, 5FR CATHETER 65CM, WAS ENGAGED INTO THE IMA. THE COIL WAS PUT THRU THIS CATHETER UPON ENTERING THE VESSEL IT WAS EVIDENT IT WAS TOO LARGE FOR THE VESSEL, UPON RETRACTING THE COIL IT BEGUN TO SHEER APART STILL STAYING ATTACHED TO THE PUSHER WIRE. A LOOP SNARE WAS USED TO PULL THE PUSHER WIRE AND COIL FROM THE PT. PT CONDITION NOT AFFECTED JUST ADDED TIME TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559452 ↗
• MalfunctionJun 5, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED IN A PROCEDURE TO TREAT AN UTERINE FIBROID EMBOLIZATION (UFE). THE COIL UNINTENTIONALLY DETACHED FROM THE PUSHER WIRE INSIDE THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT AND PROCEDURE COMPLETED USING ANOTHER COIL. CLOSURE AND RECOVERY WENT WELL WITH NO ISSUES TO THE PATIENT WHO WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154206 ↗
• MalfunctionJun 3, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A SPLENIC EMBOLIZATION PROCEDURE A COIL WAS DEPLOYED INSIDE GLIDECATH. I WAS NOT PRESENT DURING THE PROCEDURE, BUT WHEN REVIEWING THE IMAGES, IT LOOKED AS IF THERE WAS SIGNIFICANT TORTUOSITY IN THE CATHETER. I DO NOT KNOW THE SPEED OF COIL ADVANCEMENT THROUGH THE CATHETER. ACCORDING DURING THE CASE, THE PHYSICIAN WAS ADVANCING, THEN STOPPED AND HAD THE RT RECAPTURE THE COIL. THE RT DIDN'T NOTICE ANY SIGNIFICANT RESISTANCE DURING THE RECAPTURE BUT AS THE PUSHER CAME OUT, THE COIL WAS NO LONGER ATTACHED. THE CATHETER WAS WITHDRAWN AND TRASHED WITH THE COIL INSIDE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137706 ↗
• InjuryMay 16, 2025Premature Separation; Premature Separation

  AS REPORTED, THE CUSTOMER WAS USING AZUR CX 35 COIL VIA A CATHETER THROUGH A TORTUOUS SPLENIC VESSEL FOR EMBOLIZATION. DURING DEPLOYMENT, THE COIL DETACHED HALFWAY OUT OF THE CATHETER. TO ADDRESS THIS, THE PHYSICIAN USED A SYRINGE WITH SALINE TO EXPEL THE COIL FROM THE CATHETER. A PROCEDURE WAS PERFORMED USING A SNARE TO SUCCESSFULLY REMOVE THE COIL FROM THE PATIENT. NO IMPLANTS REMAIN IN THE PATIENT. THE SAMPLE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040848 ↗
• MalfunctionMay 6, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE COIL OUT OF THE CATHETER AND THEN WENT TO RETRACT IT. WHEN HE WENT TO ADVANCE IT AGAIN, THE COIL DIDN¿T MOVE. AND HE BELIEVES THE COIL WIRE BROKE OFF. IT APPEARS IT COULD HAVE BROKEN OFF AT THE SOLDER POINT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973432 ↗
• MalfunctionApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE COIL BROKE IN 2. WHEN REMOVING THE COIL CAME OUT COMPLETELY; THE DISTAL PART WAS NOT PLACED. CURRENT CONDITION OF THE PATIENT: NO INCIDENCE, DELAY IN THE PROCEDURE DUE TO THE NEED TO RE-USE A CATHETER AND RESTART THE PROCEDURE FROM SCRATCH. ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR THE CARE OF THE PATIENT: NONE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741219 ↗
• MalfunctionMar 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED: COIL WAS BEING ADVANCED THROUGH A 4F 65CM ANGLE NON TAPER GLIDE CATHETER. THE PHYSICIAN WENT TO REPOSITION COIL INSIDE THE VEIN AND FOUND THAT COIL HAD ALREADY PREMATURELY DETACHED. THEY REMOVED THE COIL STILL INSIDE THE GLIDE CATHETER COMPLETELY FROM PATIENT; ALL COIL NOTED TO BE REMOVED. PROCEDURE COMPLETED USING ANOTHER DEVICE WITH NO MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO PATIENT IMPACT OR INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660178 ↗