ECLIPSE 2L ECL2L6x7SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818053022937), received between Oct 28, 2020 and Mar 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, 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 ↗
• 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 ↗
• MalfunctionDec 15, 2020Gas/Air Leak; Physical Resistance/Sticking; Gas/Air Leak; Physical Resistance/Sticking

  IT WAS REPORTED: "PHYSICIAN WAS USING THE ECLIPSE 2L TO DELIVER ONYX IN AN AVM. HE PREPPED THE BALLOON EXACTLY AS DFU DESCRIBES AND IT APPEARED TO BE IN GOOD CONDITION. THE BALLOON INFLATED IN THE ~2.2MM VESSEL AND IT APPEARED TO WELL OPPOSE THE VESSEL WALL. WHILE DELIVERING THE ONYX, THE BALLOON APPEARED TO BE DEFLATING SLIGHTLY WHICH CAUSED THE MD TO NEED TO RE-INFLATE. THE SAME THING HAPPENED 2 OR 3 MORE TIMES. THE STOPCOCK WAS APPROPRIATELY CLOSED AFTER EACH INFLATION. UPON COMPLETION OF THE CASE AND REMOVAL OF THE BALLOON, THE VESSEL WAS PERFORATED. THE MD FELT THAT ONYX REFLUXED AROUND THE BALLOON AND CAUSED RESISTANCE TO THE WITHDRAWAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11011936 ↗
• MalfunctionOct 28, 2020Break; Break

  IT WAS REPORTED: "MMA EMBO USING ECLIPSE 6X7SN & ONYX. BALLOON WAS PUSHED FAIRLY DISTAL INTO SMALLER VESSEL AND WAS NEVER INFLATED. THE DISTAL END OF CATHETER IN TURN BECAME STUCK & BROKE OFF IN THE ONYX CAST. THE SURGEON WAS ABLE TO SNARE THE MAJORITY OF THE BROKEN CATHETER. THE PRODUCT WAS NOT ABLE TO BE SAVED TO EVALUATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10752429 ↗