ECLIPSE 2L ECL2L6x20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053023002), received between Apr 30, 2021 and Aug 26, 2022 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 30, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS POST DILATING A SURPASS AND HE COULD NOT GET THE ECLIPSE TO DEFLATE. THE TECH CALLED ME AND I ASKED THEM TO PULL TENSION ON THE BALLON AND TRY TO DEFLATE. THE BALLOON CAME DOWN AND IS AVAILABLE TO RETURN. HE FINISHED THE CASE WITH A TRANSFORM BALLOON. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755436 ↗