ECLIPSE 2LRecalls & reported problems across all models

We found 5 models of ECLIPSE 2L by Balt USA LLC in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Feb 24, 2020 and Mar 7, 2025 — classified as 1 death, 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ECLIPSE 2L problems

ECLIPSE 2L models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ECLIPSE 2L ECL2L6x9

  Catheter, Intravascular Occluding, Temporary
  14 reports
• ECLIPSE 2L ECL2L6x12

  Catheter, Percutaneous
  10 reports
• ECLIPSE 2L ECL2L6x15

  Catheter, Intravascular Occluding, Temporary
  5 reports
• ECLIPSE 2L ECL2L6x7SN

  Catheter, Intravascular Occluding, Temporary
  4 reports
• ECLIPSE 2L ECL2L6x20

  Catheter, Percutaneous
  1 death3 reports

Recent ECLIPSE 2L adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "THE PHYSICIAN USED AN ECLIPSE 2L OCCLUSION BALLOON CATH TODAY THAT WAS DEFECTIVE. HE WAS INJECTING ONYX THROUGH THE CATHETER AND THE TIP BROKE OFF. CAN WE GET A REPLACEMENT FOR THIS? THE STAFF DID NOT SAVE THE CATHETER, BUT I DO HAVE THE PACKAGING. REF# (B)(4). LOT# F240800474". INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED. ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER - 21FEB2025: "- COULD YOU PLEASE TELL US IF THE INCIDENT OCCURRED WHEN THE ECLIPSE2L WAS INSIDE OR OUTSIDE THE PATIENT? YES. - COULD YOU PLEASE TELL US HOW THE ECLIPSE WAS PREPARED? DFU. - COULD YOU PLEASE TELL US IF YOU SEE ANY DAMAGES DURING THE PREPARATION OF THE DEVICE? NO - COULD YOU PLEASE TELL US IF YOU INJECT SOMETHING INSIDE THE CATHETER OTHER THAN ONYX? YES. - COULD YOU PLEASE INFORM US ABOUT THE PATIENT CONDITION TO DATE? FINE. - COULD YOU PLEASE TELL US HOW THE PHYSICIAN ENDED-UP THE CASE? AS USUAL. - COULD YOU PLEASE TELL US IF YOU SUCCEED TO PURGE THE BALLOON? / REMOVE THE AIR FROM THE BALLOON? YES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548712 ↗
• MalfunctionMay 10, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "USED BALLOON FOR INTRODUCTION OF ONYX. PLACED BALLOON IN STRAIGHT, NON TORTOUS, LARGE VESSEL. INFLATED BALLOON AND INJECTED ONYX. WE DID NOT OBSERVE ANY ONYX PAST BALLOON. THE REFLUX STOPPED AT DISTAL END OF BALLOON. UPON CATHETER RETRACTION PHYSICIAN FELT EXCESSIVE FORCE AND CATHETER STRETCHING. CATHETER SNAPPED SOMEWHERE PROXIMAL TO BALLOON. PHYSICIAN OBSERVED THREAD LIKE MATERIAL AT END OF FRACTURED CATHETER. PHYSICIAN WAS ABLE TO DISLODGE DISTAL END AND REMOVE IT FROM PATIENT." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287158 ↗
• InjuryApr 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "PHYSICIAN WAS PERFORMING AN AVM ONYX EMBOLIZATION WITH THE ECLIPSE2L 4X12. DURING THE CASE SOME PROXIMAL REFLUX WAS SEEN, PROXIMAL TO THE BALLOON. PHYSICIAN STOPPED INJECTING AND ON THE NEXT INJECTION SAW DISTAL PENETRATION. THE AVM WAS SUCCESSFULLY EMBOLIZED. WHEN THE PHYSICIAN WENT TO PULL THE ECLIPSE THERE WAS TENSION AND WITH AS HE INCREASED FORCE THE CATHETER FELL APART INSIDE THE PATIENT. THE REMAINING PORTION WAS REMOVED AND THE PORTION THAT WAS INSIDE THE PATIENT HAD BUNCHED UP IN THE ICA AND MCA, AT WHICH POINT THE MCA WAS OCCLUDED. THE PHYSICIAN PROCEEDED WITH AN ASPIRATION SYSTEM IN THE ICA AT WHICH POINT HE WAS ABLE TO STRAIGHTEN THE REMAINING CATHETER ALONG THE VESSEL WALL. HE ATTEMPTED TO RETRIEVE THE DISTAL END WITH A STENT RETRIEVER WITH NO SUCCESS. FLOW WAS RESTORED IN THE MCA AT THE OCCLUSION OF THE CASE. THE CATHETER CAN BE SEEN IN THE BODY UNTIL THE KIDNEY." UPDATE 07MAR2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "- COULD YOU PLEASE INFORM US ON THE PATIENT CONDITION UP TO DATE? PATIENT DID SUFFER INJURY FROM THIS OCCURRENCE. - COULD YOU PLEASE CONFIRM THE INCIDENT DATE IS (B)(6) 2024? THIS WAS A TYPO, INCIDENT DATE (B)(6) 2024

  Patient problems: Stroke/CVA

  MAUDE report 19041193 ↗
• 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 ↗
• MalfunctionAug 8, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT: "DURING AN EMBOLIZATION PROCEDURE, AN ECL2L6X15 WAS USED WITHOUT INCIDENT. HOWEVER, UPON MY INSPECTION OF THE BOX FOR THE IFU, I DETERMINED THAT A MAGIC IFU WAS INSIDE THE BOX AND NOT AN ECLIPSE IFU. I SAVED THE BOX AND MAGIC IFU AND HAND DELIVERED TO BALT QA. THERE ARE TWO MORE ECL2L6X15 ON THE SHELF AT (B)(6), WITH THE SAME LOT NUMBER. I DID NOT WANT TO COMPROMISE THE LABEL AND TAPE THAT SECURE THE PACKAGING BUT SUSPECT THAT THESE TWO UNITS ALSO MIGHT ALSO HAVE A MAGIC IFU INSIDE AND NOT AN ECLIPSE IFU. IF IT IS DETERMINED THAT THE ISSUE MAY EXTEND BEYOND THIS ONE UNIT AND/OR IF THE TWO UNITS ON THE SHELF CAN AID IN THE INVESTIGATION TO DETERMINE IF THE ENTIRE LOT IS EFFECTED, PLEASE PROVIDE AN RA FOR THE UNITS AND REPLACEMENTS DELIVERED TO MY HOME ADDRESS FOR SWAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484705 ↗
• 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 ↗
• MalfunctionDec 14, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "ECLISPE 2L BALLOON STUCK IN CAST OF ONYX IN THE PATIENT. PHYSICIAN PULLED MULTIPLE TIMES AND THE BALLOON WOULDN'T RELEASE. THE CATHETER SNAPPED IN HALF AND MULTIPLE PIECES OF THE CATHETER HAD TO BE SNARED FROM THE PATIENT. THE DEBRIS WAS REMOVED AND THE BALLOON PORTION AND DISTAL CATHETER REMAINED IN THE PATIENT. PATIENT IS OKAY." 15NOV2022, ADDITIONAL INFORMATION OBTAINED BY SALES REP - " PATIENT IS HEALTHY AND HAD NO COMPLICATIONS AS A RESULT OF THIS PROCEDURE. PRODUCT HAS NOT YET BEEN RETURNED TO BALT FOR ANALYSIS DUE TO HOSPITAL'S RISK MANAGEMENT DEPARTMENT STILL HOLDING THE DEVICE IN QUARANTINE. WE ARE STILL TRYING TO OBTAIN IT FOR RETURN. TYPE OF CASE: BILATERAL MMA EMBOLIZATION WITH ONYX EMBOLIZED LEFT MMA USING 6X9 ECLIPSE WITH NO ISSUE EMBOLIZED RIGHT MMA (ANTERIOR DIVISION) USING 6X9 ECLIPSE WITHOUT ISSUE EMBOLIZED RIGHT MMA (POSTERIOR DIVISION) USING 6X7 ECLIPSE WITH SAME TECHNIQUE WHICH THEN HAD THE PROBLEM RETRACTING THE BALLOON AFTER DEFLATION AND ONYX INJECTION BALLOON WAS NEVER INFLATED FOR MORE THAN 1-1.5 MINUTES DURING INJECTION OF ONYX USED SOFIA 5F INTERMEDIATE CATHETER FOR SUPPORT AND ASSISTANCE IN RETRACTION IF NECESSARY. POSTERIOR DIVIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977961 ↗
• 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 ↗
• MalfunctionNov 23, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "PROCEDURE: MMA EMBOLIZATION WITH ONYX ECLIPSE BALLOON CATHETER USED TO DELIVER ONYX IN THE MMA (MIDDLE MENINEGEAL ARTERY) RIGHT AT THE BIFURCATION. ONYX WAS PUSHED THROUGH THE ECLIPSE CATHETER WITH SOME REFLUX, THEN THE BALLOON WAS INFLATED. AFTER INFLATION THE ONYX REFLUX RETROGRADE. THE ECLIPSE BALLOON CATHETER WAS STUCK IN THE ONYX. DRS WAITED A FEW MINUTES AND APPLIED TENSION AND LOCKED IT DOWN AT THE GROIN TO APPLY TENSION AT THE DISTAL END. THE PHYSICIANS THAN ATTEMPTED TO PUL AGAIN AND IT SNAPPED IN THE PATIENT LEAVING THE DISTAL END IN THE EXTERNAL CAROTID ARTERY. NO DAMAGE DONE TO THE PATIENT, PATIENT WOKE UP FROM THE PROCEDURE NEUROLOGICAL INTACT." 30NOV2022, ADDITIONAL INFORMATION PROVIDED BY ISSUER - "PATIENT HAS NO DEFICITS. NO PATIENT INJURY. TORTUOUS ANATOMY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852306 ↗
• DeathAug 26, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "DURING AN ONYX CASE, THE BALLOON FRACTURED AND ENDED UP OCCLUDING THE RIGHT ICA." ON (B)(6) 2022, ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "WERE ANY ADDITIONAL PROCEDURES PERFORMED BY THE PHYSICIAN? THROMBECTOMY AFTER THE BALLOON FRACTURED." ON (B)(6) 2022 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "COULD YOU PLEASE TELL US WHAT WAS THE PLANNED PROCEDURE? ONYX INJECTION THROUGH E2L FOR A FISTULA. COULD YOU PLEASE GIVE US INFORMATION ON PATIENT'S STATUS? WITHDREW CARE. CAN YOU PLEASE CONFIRM THAT THERE IS NO PATIENT INJURY? NO. WAS THE PATIENT'S ANATOMY TORTUOUS? YES."

  Patient problems: Foreign Body Embolism; Ruptured Aneurysm

  MAUDE report 15300831 ↗
• 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 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "THE BALLOON, AFTER BEING CORRECTLY PURGED AND INFLATED ONCE IN THE AREA TO BE TREATED, FAILED TO BE INFLATED FOR THE SECOND TIME. THE DISTAL PART OF THE BALLOON GET INFLATED, BUT NOT THE PROXIMAL HALF OF IT. AS THE OPERATOR KEEP PUSHING IN ORDER TO INFLATE THE PROXIMAL PART, THE DISTAL PART GET OVER INFLATED INSTEAD OF THE PROXIMAL, THAT KEEPS DEFLATED. VASSEL BREAK DUE TO THE BALLOON OVERINFLATION. FORTUNATELY THE PATIENT SURVIVED AND WILL PROBABLY RECOVER." ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "THEY PUT THE BALLOON ON THE TRASH, THEY SAID THAT THE BALLOON WAS DEFORMED AS THEY MANIPULATE IT AFTER THE CASE (ONCE OUT OF THE BODY OF THE PATIENT). HONESTLY, I CHECKED THE BALLOON JUST AFTER THEY PULL IT AWAY AND IT INFLATE AND DEFLATE CORRECTLY. SOME MINUTES AFTER, THE PHYSICIANS MANIPULATE IT AND AFTER SEVERAL TIME THEY PUT IT ON THE TRASH." "THEY INJECTED GLUE AFTER THE RUPTURE OF THE VASSEL TO STOP THE BLEEDING. THE BALLOON DID NOT RUPTURE, THE PROXIMAL PART SIMPLY DID NOT INFLATE. THE PROXIMAL PART WAS OVER-INFLATED BUT THE BALLOON DID NOT RUPTURE." "JUST ONE UNIT OF THAT BATCH NUMBER." "THE HEMORRHAGE WAS QUICKLY STOPPED BY THE INR AND THE BLOOD

  Patient problems: Rupture

  MAUDE report 14734034 ↗
• MalfunctionJun 14, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "DR. (B)(6) WAS DOING AN ONYX EMBO OF A MMA. HE WAS USING A 6X12 ECLIPSE IN A SUB 2MM VESSEL. HE WENT TO REMOVE THE BALLOON AND IT WAS STUCK IN THE CAST. AFTER SEVERAL ATTEMPTS AND STRETCHING OF THE CATHETER THE ECLIPSE BALLOON FRACTURED LEAVING A PORTION OF THE BALLOON AND CATHETER BEHIND. DR. STONE PERFORMED AN ENDARTERECTOMY TO REMOVE THE CATHETER AND BALLOON FROM THE CAROTID ARTERY. HE WAS ABLE TO RETRIEVE ALL OF THE BALLOON AND CATHETER."

  Patient problems: Insufficient Information

  MAUDE report 14685739 ↗
• MalfunctionMay 25, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT: "THE PHYSICIAN PREPPED, INSERTED, TRACKED AND INFLATED THE ECLIPSE BALLOON WITHOUT INCIDENT. HE INJECTED ONYX THEN DEFLATED THE BALLOON SUCCESSFULLY. UPON WITHDRAWAL, THERE WAS SIGNIFICANT TENSION. HE PAUSED AND STILL HAD SIGNIFICANT RESISTANCE. HE INFLATED THE BALLOON SLIGHTLY THEN DEFLATED AND ATTEMPTED TO REMOVE IT AGAIN. SLOW AND STEADY TENSION FOR 1-2 MINUTES AND THE BALLOON FINALLY DISLODGED FROM THE CAST. AFTER REMOVAL, THE ANGIOGRAM SHOWED A SIGNIFICANT DISSECTION WITH A PSEUDO-ANEURYSM AND EXTRAVASATION OF CONTRAST AT THE ORIGIN OF THE AICA. I AM NOT CERTAIN I RETAINED THE CORRECT BALLOON PACKAGE AND LOT NUMBERS SINCE THERE WERE 2 BALLOONS USED. THE 6X15 WAS USED TO STOP THE BLEEDING POST RUPTURE. THE 6X12 WAS USED FOR THE EMBOLIZATION. PRODUCT WILL BE SENT BACK." UPDATE 27APR2022 - ADDITIONAL INFORMATION PROVIDED BY THE ISSUER: "THERE DID NOT APPEAR TO BE ANY PART OF THE ECLIPSE THAT WAS LEFT IN THE PATIENT. IT WAS SUSPECTED BY THE MD THAT THE E2L CAUSED THE DISSECTION BUT IT IS IMPOSSIBLE TO PROVE. NO ISSUES WITH 6X15 E2L ONLY UPDATE I HAD WAS THAT THE PATIENT WAS AWAKE AND RESPONSIVE THE FOLLOWING MORNING. I HAVE NO FURTHER INFORMATION."

  Patient problems: Vascular Dissection

  MAUDE report 14498162 ↗

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