ECLIPSE 2L ECL2L6x12Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00818053022968), received between Apr 9, 2020 and May 10, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 7, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT: "THE ECLIPSE BALLOON BECAME ENTRAPPED AFTER USE AND THE PHYSICIAN HAD TO CUT IT AT THE GROIN ACCESS SITE." 09MAR2022 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "COULD YOU PROVIDE ADDITIONAL DETAILS ON THE INCIDENT? EVERYTHING I KNOW ABOUT THE PROCEDURE I HAVE DISCLOSED BUT THE PHYSICIAN COULD BE CONTACTED FOR ADDITIONAL INFORMATION. CAN YOU CONFIRM THAT NO HARM OCCURRED TO THE PATIENT? ACCORDING TO THE PHYSICIAN THE PATIENT WAS NOT HARMED. WAS THE PRODUCT ENTRAPPED DUE TO THE LIQUID EMBOLIC? YES, THE PHYSICIAN WAS USING ONYX APPROXIMATELY WHERE WAS THE CATHETER CUT? ACCORDING TO THE PHYSICIAN IT WAS CUT AT THE FEMORAL ARTERY ACCESS SITE." 23MAR2022 - ADDITIONAL INFORMATION FROM ISSUER: COULD YOU PLEASE TELL US HOW THE CATHETER HAD BEEN ENTRAPPED? WAS IT FOLLOWING A REFLUX OF EMBOLIC AGENT? THE PHYSICIAN COMMUNICATED TO ME THAT THE PATIENT HAD A SENSITIVE FUSIFORM BASILAR ANEURYSM THAT WAS SLOWLY SACRIFICING WITH A LIQUID EMBOLIC. ONE THE EMBOLIZATION WAS COMPLETE HE LIGHTLY PULLED ON THE ECLIPSE WITHOUT SUCCESSFUL REMOVAL BUT BECAUSE OF THE NATURE OF THE DISEASE HE DID NOT WANT TO PULL EXCESSIVELY. THEREFORE HE CUT THE CATHETER AT THE GROIN ACCESS SITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048747 ↗
• 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, THE PHYSICIAN 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849398 ↗
• MalfunctionNov 8, 2021Therapeutic or Diagnostic Output Failure

  DOCTOR WAS PERFORMING AN EMBOLIZATION PROCEDURE WITH A LIQUID EMBOLIC AGENT (ONYX) USING AN ECLIPSE 2L BALLOON CATHETERS THAT IS APPROVED FOR USE WITH THIS AGENT. IN THE COURSE OF THE PROCEDURE, A SMALL PORTION OF THE DEVICE BECAME EMBEDDED IN THE ONYX AND WAS RETAINED WITHIN PATIENT (TWICE, TWO SEPARATE CATHETERS WITH TWO SEPARATE FRAGMENTS, BOTH OF THE SAME BRAND). THIS IS NOT DESIGNED AS A BREAKAWAY CATHETER AND THEREFORE IS A DEVICE FAILURE, ALTHOUGH THIS IS A KNOWN OCCURRENCE IN THESE COMPLEX CASES. THE RETENTION IS NOT EXPECTED TO RESULT IN SIGNIFICANT INJURY AS THE FRAGMENTS ARE TOTALLY EMBEDDED IN THE ONYX.

  Patient problems: Foreign Body In Patient

  MAUDE report 12770131 ↗
• MalfunctionMay 28, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT: "THE NOSE OF THE ECLIPSE WAS STUCK IN THE ONYX 18 MASS. THE PHYSICIAN HAD TO PULL VERY HARD. MUCH HARDER THAN HE HAD TO PULL WITH OTHER CATHETERS OF BALLOONS. HE EVENTUALLY GOT IT PULLED OUT, AND THE BALLOON TIP WAS DETACHED AND THE CATHETER HAD BEEN UNRAVELED. ADDITIONAL INFORMATION: COULD YOU PLEASE CONFIRM US THAT THE TOTALITY OF THE ECLIPSE2L COULD BE REMOVED FROM THE PATIENT? NO, THEY SAID A PIECE OF THE BALLOON TIP WAS ENTRAPPED IN THE CAST. AND SEPARATED FROM THE BALLOON. COULD YOU PLEASE TELL IF THE USER OBSERVED A DEFLATION OF THE BALLOON BEFORE THE ENTRAPMENT OF THE CATHETER? YES THE BALLOON WAS FULLY DEFLATED. COULD YOU PLEASE TELL US HOW MANY CENTIMETERS OF CATHETER WAS STILLED IN THE PATIENT? WE HAVE NO CLUE. BUT I'M SURE THE ENGINEER CAN FIGURE THIS OUT WHEN THEY RECIEVE THE DEFECTIVE PRODUCT. I WILL SEND IT BACK TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904463 ↗
• MalfunctionApr 7, 2021Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS USING AN ECLIPSE 6X12 ON A FISTULA CASE. THE PHYSICIAN COULD NOT DEFLATE THE BALLOON SO HE HAD TO USE A SEPARATE WIRE TO PUNCTURE THE BALLOON TO DEFLATE. " FOLLOW UP: "COULD YOU PLEASE TELL ME IF THE CATHETER ECLIPSE 2L HAD BEEN INSERTED BY THE LATERAL OR THE AXIAL ARM OF THE CONNECTOR? LATERAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629008 ↗
• MalfunctionApr 9, 2020Break; Break

  IT WAS REPORTED THAT: "USED BALLOON FOR D FISTULA. AFTER FINAL INJECTION OF ONYX DR. TRIED PULLING ECLIPSE OUT OF ONYX CAST. THERE WAS SOME REFLUX AROUND THE BALLOON. BALLOON TIP BROKE OFF AND A STREAM OF ONYX PRESENTED IN THE VERT. HE TRIED REMOVING IT WITH PENUMBRA SECTION, HE TRIED SNARING IT OUT, HE TRIED TACKING IT WITH A WINGSPAN STENT. ENDED UP SUCKING THE VERT WITH A PLUG."

  Patient problems: Fistula

  MAUDE report 9944369 ↗