ECLIPSE 2L ECL2L6x9Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818053022944), received between Mar 19, 2020 and Sep 27, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "EMBOLIZED A PICA WITH ONYX, ONYX APPEARED TO REFLUX AROUND BALLOON. UPON REMOVAL OF THE CATHETER, ECLIPSE SNAPPED, LEAVING THE DISTAL END IN THE VESSEL." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824838 ↗
• MalfunctionJul 22, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT: "AFTER PLACING A PIPELINE FLOW DIVERTER THE ECLIPSE BALLOON WAS USED TO MAKE SURE PROPER WALL APPOSITION WAS REACHED. THE BALLOON WAS OPENED 3 TIMES INSIDE THE STENT WITHOUT ANY ISSUES. ON THE FOURTH AND LAST INFLATION OF THE BALLOON IT WOULD NOT DEFLATE. THE TEAM TRIED MANY DIFFERENT THINGS TO DEFLATE THE BALLOON AND IT WAS INSIDE THE PIPELINE AND WOULD NOT DEFLATE. AN INTERMEDIATE CATHETER WAS TRACKED UP TO THE BALLOON, AND WAS THEN PUSHED INTO THE BALLOON TO ULTIMATELY SLIDE THE BALLOON INTO THE INTERMEDIATE CATHETER AND GET IT OUT. THE TEAM WANTS TO KNOW WHAT WAS WRONG WITH THIS BALLOON, AND WHY IT DID NOT WANT TO DEFLATE AFTER INFLATING AND DEFLATING 3 TIMES PRIOR WITHOUT INCIDENT." INCIDENT REPORT FORM SUBMITTED FOR THIS EVENT INDICATED NO PATIENT INJURY WAS SUSTAINED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375426 ↗
• MalfunctionApr 10, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "PHYSICIAN WAS TREATING A SUBDURAL HEMATOMA PATIENT BY EMBOLIZING THE MMA. A BENCHMARK CATHETER WAS PLACED THROUGH A SHORT SHEATH INTO THE LEFT EXTERNAL CAROTID ARTERY. A 6X9 ECLIPSE BALLOON CATHETER WAS PREPPED ACCORDING TO THE IFU AND WAS ADVANCED THROUGH THE BENCHMARK INTO A DISTAL BRANCH OF THE LEFT MMA. THE VESSEL MEASURED BETWEEN 1.3MM AND 1.5MM AND IT WAS IMPORTANT THAT AN OPTHALMIC BRANCH WAS PROTECTED SO THE USE A BALLOON DURING EMBOLIZATION WAS IMPORTANT. THE BALLOON WAS INFLATED AND ONYX 18 WAS INJECTED THROUGH THE CATHETER UNTIL ALL DISTAL MMA BRANCHES WERE OCCLUDED. NO REFLUX WAS NOTICED DURING THE INJECTION SO THE BALLOON WAS DEFLATED AND UPON REMOVAL OF THE CATHETER THERE WAS SIGNIFICANT RESISTANCE IN REMOVING THE CATHETER. THE PHYSICIAN PLACED GENTLE TRACTION ON THE CATHETER TO ENSURE A SAFE REMOVAL AND AFTER ABOUT 5 MINUTES OF GENTLE TRACTION THE CATHETER BROKE. IT WAS NOTICED UPON ANGIO THAT SEVERAL CM'S OF CATHETER REMAINED IN THE MMA AND EXTERNAL CAROTID ARTERY. THE DECISION WAS MADE TO LEAVE THE CATHETER FRAGMENT WHERE IT WAS. THE PHYSICIAN COMMENTED "HE IS DOING GREAT SO FAR" ABOUT 24 HOURS AFTER THE PROCEDURE." 20MAR2023, ADDITIONAL INFO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707339 ↗
• MalfunctionNov 30, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "PROCEDURE (B)(6) 2022 DAV FISTUALA. INFLATED BALLON IN MIDDLE MENINGEAL ARTERY. ACHIEVED EMBOLIZATION. THERE WAS 1CM FOR REFLUX. DEFLATED BALLOON, AND TRIED TO REMOVE IT FROM ONYX CAST. FELT A STRETCHING. WHEN CATHETER WAS REMOVED FROM THE CATHETER, IT WAS STRETCHED. THE TIP APPEARED TO BE MISSING. PATIENT APPEARS TO BE FINE" INCIDENT REPORT FORM RECEIVED FOR THIS EVENT INDICATED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890050 ↗
• MalfunctionAug 26, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "THE 6X9 ECLIPSE BALLOON WAS ADVANCED OVER THE SYNCHRO WIRE INTO DISTAL BRANCH JUST PROXIMAL TO THE FISTULA. THE SYNCHRO WIRE WAS REMOVED AND DMSO WAS INJECTED INTO THE WORKING LUMEN, 0.3. THE ECLIPSE BALLOON WAS SLIGHTLY INFLATED AND ONYX WAS DELIVERED TO THE FISTULA WITHOUT ISSUE. THEN, A SMALL AMOUNT OF ONYX REFLUXED AROUND THE BALLOON. THE EMBOLIZATION WAS LARGELY COMPLETED WITHIN 7 MINUTES. THE BALLOON WAS DEFLATED AND UPON REMOVAL THE BALLOON WAS STUCK . EVENTUALLY, THE BALLOON CATHETER WAS REMOVED AFTER A FEW MINUTES OF PULLING. THE TIP OF THE BALLOON WAS LEFT BEHIND AND THE CATHETER ITSELF WAS EXTREMELY STRETCHED. THE TIP OF THE BALLOON WAS LEFT BEHIND IN THE EMBOLIZED VESSEL, SO IT WAS NOT OF MAJOR CONCERN. BUT, GETTING THE BALLOON STUCK SO QUICKLY WAS CONCERNING IN A 7 MINUTE INJECTION, SAID THE PHYSICIAN. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300829 ↗
• MalfunctionApr 15, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "PHYSICIAN WAS TREATING A DAVF IN A 50YO FEMALE. AFTER FOLLOWING THE IFU TO CORRECTLY PREP THE ECLIPSE BALLOON, THE PHYSICIAN SUCCESSFULLY TRACKED AN ECLIPSE DL BALLOON (USING AN ARISTOTLE WIRE) INTO THE MAIN FEEDER OF THE DAVF, WHICH WAS OFF THE POSTERIOR OCCIPITAL ARTERY. THE BALLOON WAS INFLATED, ONYX 18 WAS INJECTED AND THE BALLOON WAS DEFLATED AND THE CATHETER WAS REMOVED. ANGIOGRAPIC CONFIRMATION WAS MADE THAT THE FIRST EMBOLIZATION WAS SUCCESSFUL. A SECOND FEEDER WAS LOCATED FOR THE DAVF AND AGAIN THE BALLOON WAS PREPPED WITH 70/30 CONTRAST TO SALINE (FOLLOWING THE IFU). THE BALLOON WAS TRACKED INTO ANOTHER SMALLER (1.6MM) BRANCH AND THE BALLOON WAS INFLATED AND ONYX 18 WAS INJECTED THROUGH THE ECLIPSE. DURING THE INJECTION A SMALL AMOUNT OF REFLUX WAS NOTICED, EXTENDING MOST OF THE WAY ALONG THE BALLOON. WE PAUSED AND INFLATED THE BALLOON MORE AND CONTINUED WITH THE INJECTION. THE INJECTION WAS SUCCESSFUL WITH GOOD PENETRATION AND WE AGAIN NOTICED THAT WE HAD REFLUX EVEN FURTHER BACK ALONG THE SHAFT OF THE CATHETER THAT NOW EXTENDED WELL PROXIMAL TO THE BALLOON. WE STOPPED THE INJECTION AND DEFLATED THE BALLOON AND BEGAN TO REMOVE THE BALLOON. IT WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14123021 ↗
• MalfunctionFeb 24, 2022Break; Entrapment of Device; Detachment of Device or Device Component; Break; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "AFTER FOLLOWING THE IFU TO CORRECTLY PREP THE ECLIPSE BALLOON, THE PHYSICIAN SUCCESSFULLY TRACKED AN ECLIPSE DL BALLOON (USING A HYBRID 12/14) TO THE MAIN FEEDING PEDICLE, ARISING FROM THE ANTERIOR TEMPORAL ARTERY ON THE PATIENTS LEFT SIDE. THE BALLOON WAS INFLATED USING A MIXTURE OF 70/30 CONTRAST TO SALINE AND ONYX 18 WAS THE INJECTED THROUGH THE ECLIPSE. A SMALL AMOUNT OF REFLUX WAS NOTICED, EXTENDING ABOUT 50% OF THE WAY BACK FROM THE TIP OF THE BALLOON AND AFTER A BRIEF PAUSE, THE INJECTION WAS CONTINUED UNTIL ANOTHER SLIGHT REFLUX OF ONYX WAS NOTICED AGAIN ABOUT 50% OF THE WAY BACK ON THE BALLOON. THE BALLOON WAS INFLATION WAS INCREASED AND THE INJECTION OF ONYX WAS CONTINUED. AFTER WHAT APPEARED TO BE A COMPLETE EMBOLIZATION, THE BALLOON WAS DEFLATED, AND THE PHYSICIAN BEGAN TO REMOVE THE ECLIPSE BALLOON CATHETER. ONYX REFLUX WAS NOTED TO EXTEND TO THE TIP OF THE BALLOON (ALONG THE DISTAL 7MM TIP OF THE ECLIPSE CATHETER) BUT WAS NOT NOTED TO EXTEND DOWN TO THE AREA OF THE BALLOON OR PAST THE BALLOON. THE CATHETER APPEARED TO BE STUCK AS THE CATHETER WAS BEING REMOVED. THE PHYSICIAN PLACED GENTILE TRACTION ON THE CATHETER FOR OVER 10 MINUTES, IN THE HOP

  Patient problems: Foreign Body Embolism

  MAUDE report 13595801 ↗
• MalfunctionNov 19, 2021Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT: "DURING THE 10TH TREATMENT OF A VERY COMPLEX FISTULA IN A 14 YR OLD MALE, DR.(B)(6) ADVANCED A 6X12 ECLIPSE BALLOON OUT A DEEP CERVICAL ARTERY AND INJECTED ONYX. DURING THE INJECTION PERIOD, ONYX CAME BACK ON THE BALLOON AND ENTRAPPED THE CATHETER IN THE DISTAL, TORTUOUS ANATOMY. DURING REMOVAL OF THE ECL 6X12 THERE WAS SIGNIFICANT RESISTANCE, AND THE RESULT WAS A FRACTURED DISTAL SEGMENT OF THE CATHETER. IN A SECOND PEDICLE, WHICH WAS LESS TORTUOUS AND LESS DISTAL, A SIMILAR SITUATION AROSE. A SECOND ECLIPSE WAS PULLED (SIZE WAS A 6X9) AND BECAME ENTRAPPED IN AN ONYX CAST AND FRACTURED UPON REMOVAL. OVERALL THE ANATOMY WAS CONSIDERED "TORTUOUS" AND THE PROCEEDURE WAS CONSIDERED "VERY COMPLEX". 17 VIALS OF ONYX WERE SUCCESSFULLY ADMINISTERED. THIS WAS THE 10TH TREATMENT FOR THE PATIENT WHOSE PROGNOSIS IS POOR (UNRELATED TO CATHETER FRACTURE). NO ADVERSE EVENTS WERE OBSERVED DUE TO MICROCATHETER FRACTURE. DR. AMANS COMMENTED THAT THE FRACTURED CATHETERS DID NOT HAVE NEGATIVE IMPACT ON PATIENT OUTCOME. THE BALLOON FRAGMENTS ARE WITHIN THE ONYX CAST. AFTER THE PROCEEDURE THE PATIENT WAS AWAKE AND ALERT. - BOTH UNITS PREPPED PER DFU. - A 6F BENCHMARK WAS USED AS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848500 ↗
• MalfunctionOct 7, 2021Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT: "THE ECLIPSE 6X9 WAS ADVANCED WITHOUT ISSUE OVER A SYNCHRO TO AN ADJOINING VESSEL TO A AVM OFF THE ICA TRUNK NEAR THE ANTERIOR CHOROIDAL ARTERY. THE ECLIPSE WAS INFLATED AND ONYX WAS DELIVERED WITHOUT ISSUE INTO THE AVM. THE BALLOON WAS DEFLATED AND SEEMED STUCK IN THE VESSEL(OFF OF THE ICA), ENTRAPPED IN AN ONYX CAST AFTER USE IN A AVM. AFTER PULLING ON THE ECLIPSE (DR. (B)(6)) TO REMOVE FOR 20 MINS, THE ECLIPSE POPPED FREE AND WAS REMOVED. UPON REVIEW, THE INNER LINING OF (HYPOTUBE WIRES) HAD PULLED THROUGH THE CATHETER AND WERE IN THE ICA. DR. (B)(6), STENTED THE EXISTING WIRES TO THE VESSEL WALL AND ACHIEVED A POSITIVE ANGIOGRAPHIC RESULT. PATIENT WAS DOING WELL FOLLOWING PROCEDURE. FOLLOW UP 15SEP2021: AFTER THE BALLOON CATHETER WAS REMOVED, DR. (B)(6) NOTICED WIRES FLOATING IN THE INTERNAL CAROTID ARTERY UNDER FLUOROSCOPY, JUST DISTAL TO THE TIP OF THE NEURONMAX SHEATH. THE BALLOON CATHETER HAD A SMALL WIRE PROTRUDING FROM THE CATHETER. WE ASSUMED THE CATHETER HAD TORN SOMEWHERE, AND THE HYPOTUBE WIRES (WITHIN THE CATHETER) HAD PULLED OUT. DR. (B)(6) STENTED THE WIRES WITH 3 ATLAS STENTS TO PLASTY THE WIRES AGAINST THE VESSEL WALL. THE PATIENT LOOKED ANG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595167 ↗
• MalfunctionApr 9, 2021Break; Failure to Eject; Break; Failure to Eject

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS COMPLETING AN ONYX EMBOLIZATION FOR A DAVF USING A ECLIPSE2L6X9. DURING THE INJECTION THERE WAS A "REENTRY POINT" FROM THE FISTULA WHICH ALLOWED SOME ONYX TO COME IN CONTACT WITH THE BALLOON CATHETER AT A MORE PROXIMAL LOCATION (4-5CM PROXIMAL). UPON COMPLETION OF THE PROCEDURE HE WAS ATTEMPTING TO REMOVE THE ECLIPSE2L 6X9. THE BALLOON WOULD NOT COME OUT. HE PULLED PRESSURE AND RELEASED PRESSURE FOR APPROXIMATELY 30 MINUTES UNTIL THE CATHETER STRETCHED AND BROKE AT APPROXIMATELY 140CM. THE BALLOON AND ALL THREE RADIOPAQUE MARKERS WERE STUCK IN THE OCCIPITAL ARTERY. THE PHYSICIAN ENSURED THAT IT WAS DISTAL ENOUGH THAT IT COULD NOT COME BACK INTO THE COMMON CAROTID ARTERY AND CAUSE AN EMBOLUS. THE PATIENT WOKE UP OK AND DID NOT HAVE ANY COMPLICATIONS DUE TO THIS ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642254 ↗
• MalfunctionMar 23, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS TREATING A RECENTLY RUPTURED AVM IN WHICH THE PATIENT WAS PARALYZED DUE TO THE PREVIOUS HEMORRHAGE. THE PHYSICIAN DECIDED TO EMBO THIS RECENTLY RUPTURED AVM WITH ONYX USING AN ECLIPSE 6X9 BALLOON. THE PHYSICIAN HAD ACCESSED A DISTAL ACA BRANCH, BLEW THE BALLOON UP AND BEGAN INJECTING ONXY. THE BALLOON AND CATHETER TIP BECAME LODGED IN THE ONYX CAST. WHEN THE PHYSICIAN WENT TO REMOVE THE STUCK BALLOON AND CATHETER THE VESSEL TORE CAUSING EXTRAVASATION. THE PHYSICIAN QUICKLY USED A MARATHON TO GLUE OFF THE TEAR.IN THE VESSEL. THE PATIENT IS IN OK AND IN SAME CONDITION AS BEFORE. PATIENT WAS ALREADY PARALYZED DUE TO THE INITIAL HEMORRHAGE OF AVM."

  Patient problems: Perforation of Vessels

  MAUDE report 11557113 ↗
• MalfunctionFeb 16, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "BALLOON DEFORMED FROM PACKAGING - CATHETER TIP BENT. CLASSIFIED AS ATRAUMATIC AFTER INSPECTION BY AN INTERVENTIONALIST, THUS FINALLY INTRODUCED INTO THE PATIENT AND TRIED TO INFLATE, THIS WAS NOT POSSIBLE AFTER IT WAS FOUND THAT THE BALLOON MIGHT HAVE A LEAK. NO CONSEQUENCES HERE, EXCEPT DELAY IN NEUROINTERVENTION. POSSIBLE CONSEQUENCES: DIFFICULTIES IN RECOVERING THE CATHETER; FALSIFIED EXAMINATION RESULT" FOLLOW UP (04-FEB-2021) *DECISION TO REPORT: "WE FURTHER ANALYZED AND EVALUATED AGAIN THE RISK "INFLATION ISSUE" DURING USE IN THE PATIENT WITH THE SUPPORT OF R&D, REGULATORY AND CLINICAL AFFAIRS DEPARTMENTS AND ONE OF OUR EXPERTS, PROFESSOR (B)(6), HEAD OF NEURORADIOLOGY DEPARTMENT OF (B)(6). THIS STUDY ALLOWED US TO ADJUST OUR RISK ANALYSIS DOCUMENTATION FOLLOWING OUR INTERNAL RISK PROCESS BY ADDING MORE CLARIFICATION TO THE HAZARDOUS SITUATION "BALLOON LEAKAGE" WITH ADDITION OF A POTENTIAL HARMS IN CASE THE INFLATION ISSUE WOULD OCCUR DURING AN EMERGENCY PROCEDURE. AS MENTIONED IN THE INSTRUCTIONS FOR USE, THE BALLOON IS USED TO PROTECT THE VESSELS BY TEMPORARY OCCLUSION. IN VERY SPECIFIC SITUATIONS, WHICH HAVE NEVER BEEN REPORTED TO US DURING THE 5 YEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333789 ↗
• MalfunctionJan 13, 2021Break; Failure to Eject; Break; Failure to Eject

  IT WAS REPORTED THAT: "PHYSICIAN WAS USING THE ECLIPSE 2L TO DELIVER ONYX IN A DISTAL FISTULA. HE PREPPED THE BALLOON EXACTLY AS DFU DESCRIBES AND IT APPEARED TO BE IN GOOD CONDITION. THE BALLOON PERFORMED WELL AS EXPECTED WITH INFLATION AND DEFLATION. UPON ATTEMPTED REMOVAL, AFTER DEFLATION, THE BALLOON COULD NOT BE REMOVED FROM THE VESSEL WITH A NORMAL AMOUNT OF FORCE. DR. CAWLEY THEN HAD TO USE A TREMENDOUS AMOUNT OF FORCE TO REMOVE THE BALLOON. THE BALLOON CATHETER STRETCHED AND ULTIMATELY BROKE LEAVING THE BALLOON AND PART OF THE CATHETER IN THE MMA." ADDITIONAL INFORMATION: NO PATIENT INJURY COULD YOU PLEASE TELL IF THE USER OBSERVED A LEAKAGE OF ONYX ? ((B)(6)) NO HE DID NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11163986 ↗
• MalfunctionMar 19, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: "AFTER PERFECT PREP OF THE ECLIPSE BALLOON, THE BALLOON WAS INTRODUCED INTO THE EXTERNAL CAROTID AND ONYX WAS INJECTED. AFTER SOME ONYX REFLUXED THE BALLOON WAS INFLATED BUT IT DID NOT STAY INFLATED DESPITE LOCKING THE STOPCOCK. IT WAS ATTEMPTED A SECOND TIME AND IT DEFLATED AGAIN. THE BALLOON CATHETER WAS THEN ADVANCED, AND THE ONYX INJECTION WAS COMPLETED. UPON ATTEMPT TO REMOVE THE BALLOON IT DID NOT COME OUT OF THE BODY. THE BALLOON PORTION OF THE CATHETER EVENTUALLY BROKE OFF AND REMAINED IN THE ONYX CAST. THE REST OF THE BALLOON CATHETER WAS SAFELY REMOVED. PER THE HOSPITAL PROTOCOL THE BALLOON WILL BE INSPECTED BY THEIR QUALITY TEAM AND THEN RETURNED TO BALT FOR INSPECTION."

  Patient problems: Hematoma

  MAUDE report 9855514 ↗