ECLIPSE 2L ECL2L6x15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818053022982), received between Feb 24, 2020 and Aug 8, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionFeb 5, 2021Deflation Problem; Failure to Deflate; Deflation Problem; Failure to Deflate

  IT WAS REPORTED THAT: "THE PHYSICIAN HAS USED MANY ECL 2L BALLOONS AND IS VERY COMPETENT IN PREP AND USAGE. IT IS REPORTED THAT THE BALLOON WAS PREPPED AS USUAL AND INFLATION/ DEFLATION TEST WAS FINE. THE BALLOON WAS USED TO ASSIST IN THE COILING OF AN ACUTELY RUPTURED ICA ANEURYSM. THE BALLOON WAS USED IN CONJUNCTION WITH A 6F BENCHMARK 95CM GUIDING CATHETER, A SYNCHRO2 GUIDEWIRE WAS USED WITH THE BALLOON AND AN ECHELON10 CATHETER WAS USED FOR COILING. THE CONTRAST SOLUTION WAS OMNIPAQUE 80/20 SALINE AND A 1ML SYRINGE WAS USED TO INFLATE THE BALLOON. THE BALLOON WAS INFLATED FOR THE INITIAL COIL TO BE PLACED BUT IT WOULD NOT DEFLATE. A SECOND SYRINGE WAS ALSO USED TO TRY ANS DEFLATE BUT AGAIN THIS WAS UNSUCCESSFUL. THE PHYSICIAN TOOK THE SYRINGE OFF AND THE BALLOON DEFLATED GRADUALLY OVER THE COURSE OF THE PROCEDURE. THE PATIENT SUFFERED NO ADVERSE EVENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11289666 ↗
• InjuryFeb 24, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "DURING EMBOLIZATION OF SPINAL ARTERY, MD OVER INFLATED THE ECLIPSE DUAL LUMEN BALLOON BEYOND WHAT WAS RECOMMENDED FOR THE SIZE OF THE ARTERY. THE BALLOON CAUSED A RUPTURE OF THE ANTERIOR SPINAL ARTERY. THE MD PLACED COILS THROUGH THE BALLOON TO SHUT DOWN THE VESSEL. THE MD THEN INJECTED SOME ONYX THROUGH THE ECLIPSE. THE PROCEDURE SEEMED SUCCESSFUL UNTIL HE TRIED TO REMOVE THE ECLIPSE. THERE APPEARED TO BE A CHUNK OF ONYX (AND COIL) THAT STUCK TO THE BALLOON CATHETER TIP WHEN WITHDRAWING. HE STOPPED WITHDRAWAL AND ATTEMPTED TO ADVANCE THE INTERMEDIATE CATHETER (CAT5) INTO THE ASA TO CAPTURE THE ONYX AND COIL. THE CAT5 COULD NOT GET INTO THE ASA. HE CONTINUED TO WITHDRAW THE ECLIPSE AND THE CHUNK OF ONYX AND COIL DISLODGED FROM THE ECLIPSE TIP. UPON FOLLOW-UP THERE DID NOT SEEM TO BE A NEGATIVE IMPACT ON THE PATIENT'S STATUS AS A RESULT OF THE PROCEDURAL COMPLICATION."

  Patient problems: Aneurysm

  MAUDE report 9747878 ↗
• MalfunctionFeb 24, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "DURING BALLOON ASSISTED COILING, THE 6X15 INFLATED AND DEFLATED AS EXPECTED DURING PLACEMENT OF FIRST COIL. DURING PLACEMENT OF SECOND COIL, INFLATION WAS AS EXPECTED, BUT DURING DEFLATION THE BALLOON WOULD NOT COMPLETELY DEFLATED USING 1 CC SYRINGE. THE PHYSICIAN SWITCHED TO 20 CC SYRINGE TO INCREASE DEFLATION FORCE, BUT BALLOON CONTINUED TO STAY PARTIALLY INFLATED. THE PHYSICIAN MOVED ECLIPSE 2L SLIGHTLY MORE PROXIMAL, TO STRAIGHTER SEGMENT, AND BALLOON COMPLETELY DEFLATED WAS SAFELY REMOVED FROM PATIENT. COILING WAS COMPLETED WITHOUT BALLOON ASSIST. ON BACK TABLE, THE TECH AND PHYSICIAN EACH COMPLETED AN INFLATION AND DEFLATION. THE BALLOON WOULD COMPLETELY DEFLATE, BUT IT TOOK LONGER THAN EXPECTED TO COMPLETELY DEFLATE. THE PHYSICIANS ALSO NOTED DURING THE PROCEDURE THAT THE BALLOON APPEARED TO INFLATE MORE MID AND DISTAL AND THAT THE PROXIMAL PART OF BALLOON DID NOT APPEAR TO INFLATE, OR AT LEAST MATCH THE DIAMETER OF INFLATION OF THE MID TO DISTAL PORTION. THE BALLOON WAS SET UP WITH 70/30 CONTRAST SALINE. THE BALLOON DID APPEAR TO TAKE LONG TO DEFLATE IN PREP, BUT IT INFLATED WELL AND COMPLETELY DEFLATED DURING THE TWO TIMES DURING PREP. THE SET UP INC

  Patient problems: Aneurysm

  MAUDE report 9747866 ↗