Coda G36042Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002360426), received between Nov 7, 2017 and Jun 13, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJun 13, 2018Material Rupture

  IT WAS REPORTED THAT DURING THE EVAR PROCEDURE, WHEN THE CODA BALLOON CATHETER WAS USED, THE BALLOON RUPTURED. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598285 ↗
• MalfunctionJun 13, 2018Leak/Splash; Split

  THE COMPLAINANT REPORTED THAT A LEAKAGE WAS FOUND IN THE CODA BALLOON CATHETER DURING THE PROCEDURE. IT WAS FURTHER NOTED THAT THERE WAS A SPLIT IN THE ENTIRE LENGTH OF THE BALLOON. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7596871 ↗
• MalfunctionDec 15, 2017Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  THE USER FACILITY REPORTED THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). A MAINBODY STENT GRAFT AND TWO LEGS WERE PLACED. THE PROXIMAL SIDE OF THE CONTRALATERAL LEG WAS SLIGHTLY PROTRUDING INTO THE MAINBODY. A COMPETITOR'S BALLOON WAS USED TO PERFORM A TOUCH UP OF THE STENT GRAFT, BUT THE BALLOON RUPTURED. THE REPORTER ADVISED THE BALLOON MAY HAVE BEEN RUPTURED DUE TO THE PROTRUDING CONTRALATERAL LEG. ANOTHER OF THE SAME BALLOON WAS USED TO PERFORM THE TOUCH UP. THEN A COOK CODA BALLOON CATHETER WAS USED TO TREAT A SMALL ENDOLEAK WHICH APPEARED TO BE A PROXIMAL TYPE I ENDOLEAK AT THE PROXIMAL SIDE OF THE MAIN BODY. THERE WAS NO INFORMATION REGARDING THE CODA BALLOON HAVING A PROBLEM DURING PREPARATION. WHEN THE USER ATTEMPTED TO INFLATE THE CODA BALLOON AROUND THE PROXIMAL SIDE OF THE MAINBODY, THE BALLOON WOULD NOT INFLATE AND CONTRAST LEAKED. A SECOND SAME SIZE CODA BALLOON WAS USED, HOWEVER THE SAME THING OCCURRED. AS NOTED BY THE REPORTER, THEY ATTEMPTED TO INFLATE BOTH OF THESE BALLOONS AWAY FROM THE PROXIMAL SIDE OF THE LEG INSIDE OF THE MAINBODY. THE USER THEN USED THE ALTERNATE MANUFACTURERS BALLOON TO CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7123805 ↗
• MalfunctionDec 4, 2017Material Rupture; Material Rupture

  THE USER FACILITY REPORTED THAT AN EMERGENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED. THE CODA BALLOON CATHETER WAS USED FOR TOUCH-UP BALLOONING. THE BALLOON RUPTURED DURING USE. ANOTHER BALLOON WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7081691 ↗
• MalfunctionNov 7, 2017Material Rupture; Material Rupture

  THE USER FACILITY REPORTED THAT THE (B)(6) PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE PATIENT ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE AND THE PROCEDURE WAS PERFORMED AS LABELED. ANOTHER MANUFACTURER'S GUIDE WIRE WAS USED. BEFORE FINAL ANGIOGRAPHY, THE CODA BALLOON CATHETER WAS USED TO SEAL THE PROXIMAL SIDE, BUT IT RUPTURED DURING USE. ANOTHER CODA BALLOON CATHETER WAS USED INSTEAD TO CONTINUE THE PROCEDURE. THERE HAS BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED. THE PATIENT HAS BEEN REPORTED TO BE ¿RECOVERED¿.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005602 ↗