Coda G53024Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002530249), received between May 2, 2017 and Jan 15, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A COOK CODA BALLOON CATHETER CONTAINED FOREIGN MATTER. DURING A COOK ZENITH FENESTRATED PROCEDURE, THE DEVICE WAS OPENED FOR USE. WHEN THE DEVICE PACKAGE WAS OPENED, FOREIGN MATTER, RESEMBLING HAIR WAS FOUND INSIDE THE PACKAGING BY THE CAP THAT COMES ON THE BALLOON. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079972 ↗
• MalfunctionAug 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS FOUND IN THE STERILE PACKAGING OF A CODA BALLOON CATHETER PRIOR TO USE. AFTER ENDOLUMINAL STENTING OF AN ABDOMINAL AORTIC ANEURYSM, WHILE PREPARING FOR POST-STENT DILATATION WITH COOK'S CODA BALLOON, THE HAIR-LIKE FIBER WAS FOUND IN THE PRODUCT'S STERILIZED PACKAGE. THE PRODUCT WAS NOT USED, AND A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22704960 ↗
• MalfunctionJan 7, 2020Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION REGARDING THE EVENT WAS RECEIVED ON 11FEB2020. IT WAS REPORTED THAT THE DEVICE WAS REPLACED BY ANOTHER TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9559628 ↗
• MalfunctionApr 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552064 ↗
• MalfunctionJun 14, 2018Material Rupture

  THE COMPLAINANT REPORTED THAT THE CODA BALLOON CATHETER WAS USED WITH ANOTHER MANUFACTURER'S DEVICE FOR THE EVAR (ENDOVASCULAR ANEURYSM REPAIR). THE BALLOON WAS INFLATED FOR TOUCH-UP, BUT THE BALLOON RUPTURED AFTER SEVERAL INFLATIONS. A LONGITUDINAL TEAR WAS NOTED ON THE COMPLAINT DEVICE. ANOTHER CODA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE, AND 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 7601553 ↗
• MalfunctionJun 13, 2018Air Leak

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE AND USE OF A CODA BALLOON CATHETER, THERE WAS CONNECTION FAILURE AT THE STOP COCK AS AIR WAS SEEPING FROM THE SYRINGE. THE STOPCOCK AND SYRINGE WERE REPLACED BUT AIR CONTINUED TO LEAK. IT WAS THEN CONFIRMED THAT THE CLEAR HUB WAS FAULTY AND HAD MADE AIR REMOVAL FROM THE BALLOON DIFFICULT. ANOTHER CODA BALLOON WAS USED TO PERFORM THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598417 ↗
• MalfunctionJun 13, 2018Hole In Material; Inflation Problem

  IT WAS REPORTED THAT DURING THE EVAR PROCEDURE AND USE OF A CODA BALLOON CATHETER, THE BALLOON WOULD NOT DILATE BECAUSE OF A PINHOLE IN IT. 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 7597617 ↗
• MalfunctionJun 11, 2018Material Rupture

  THE COMPLAINANT REPORTED THAT THE PHYSICIAN PERFORMED BALLOONING WITH THE CODA BALLOON CATHETER AFTER PLACING THE ENDOVASCULAR GRAFTS FOR AN AAA (ABDOMINAL AORTIC ANEURYSM). HOWEVER, THE BALLOON RUPTURED UPON ITS FIRST INFLATION. THE PHYSICIAN USED ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE EVAR (ENDOVASCULAR ANEURYSM REPAIR). THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE REPORTED PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589513 ↗
• MalfunctionFeb 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE CODA BALLOON CATHETER WAS USED TO PERFORM TOUCH-UP BALLOONING, HOWEVER THE BALLOON RUPTURED DURING FIRST INFLATION AT PROXIMAL NECK. ANOTHER CODA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT PROBLEMS. IT WAS CONFIRMED THAT WHEN THE BALLOON RUPTURED, IT WAS INFLATED ABOUT 25 ML ~ 30 ML. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THE REPORTED ISSUE. THE PATIENT¿S CURRENT STATUS HAS BEEN REPORTED AS ¿RECOVERED¿.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278108 ↗
• MalfunctionJan 17, 2018Material Rupture; Material Rupture

  THE CALCIFICATION WAS CONTAINED OUTSIDE OF THE GRAFT. NO RESISTANCE WAS FELT WHILE ADVANCING THE BALLOON. A PART OF THE BALLOON WAS OUTSIDE THE GRAFT WHEN BEING INFLATED. THE SALINE TO CONTRAST RATIO WAS 1:1 ~ 1:2. THE INFLATION VOLUME COULD NOT BE DETERMINED BECAUSE THE PHYSICIAN INFLATED THE BALLOON ON HIS FEEL WITH WATCHING THE FLUOROSCOPE SCREEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7199264 ↗
• MalfunctionJan 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE USING ANOTHER MANUFACTURER'S GRAFT AGAINST A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE LEFT FEMORAL ARTERY WAS CUT DOWN AND ANOTHER MANUFACTURER'S SHEATH WAS ADVANCED TO THE TARGET LESION. THEN IN PREPARATION AND PRIOR TO USE, THE PHYSICIAN PURGED ALL AIR FROM THE BALLOON WITHOUT PROBLEM. THE CODA BALLOON CATHETER WAS INSERTED INTO THE PATIENT¿S BODY AND THE BALLOON WAS INFLATED TO BLOCK THE FLOW OF THE AORTA. AN ANGIOGRAPHIC CATHETER WAS INSERTED FROM THE BRACHIAL ARTERY AND ANGIOGRAPHY OF THE AORTA WAS CONDUCTED, WHICH CONFIRMED FLOW OF THE AORTA WAS NOT OCCLUDED USING THE BALLOON. THE PHYSICIAN INJECTED ADDITIONAL INFUSION FLUID INTO THE BALLOON. LEAKAGE OF THE CONTRAST MEDIA FROM THE BALLOON WAS THEN CONFIRMED. SINCE RUPTURE OF THE BALLOON WAS SUSPECTED, THE DEVICE WAS RETRIEVED OUT THE BODY AND ANOTHER CODA BALLOON WAS USED INSTEAD. THE FLOW OF THE AORTA WAS BLOCKED WITHOUT ANY PROBLEMS AND THE EVAR WAS COMPLETED SUCCESSFULLY. ALTHOUGH REQUESTED, NO INFORMATION HAS BEEN PROVIDED ON THE STATUS OF THIS PATIENT OR IF THERE WERE ANY ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THIS REPORTE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7196040 ↗
• MalfunctionOct 19, 2017Material Rupture; Material Rupture

  THE USER FACILITY REPORTED AN (B)(6) FEMALE PATIENT, (B)(6) WAS SUFFERING FROM AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING AN AORFIX STENT GRAFT MAIN BODY AND CONTRALATERAL LEG. AS REPORTED, THE PATIENT¿S ANATOMY WAS SUITABLE FOR THE PLACEMENT OF ANOTHER MANUFACTURER'S. THE MAIN BODY WAS IMPLANTED BY LEFT FEMORAL APPROACH AND THE CONTRALATERAL LEG PLACED BY RIGHT FEMORAL APPROACH. THE FACILITY REPORTED, AFTER THE AORFIX WAS PLACED IN THE AORTA, THE CODA BALLOON CATHETER BALLOON WAS USED FOR TOUCH-UP BALLOONING. WHEN THE AIR OF THE BALLOON WAS PURGED FOLLOWING THE INSTRUCTIONS FOR USE (IFU), DURING PREPARATION OUTSIDE THE BODY AND PRIOR TO INSERTION, THERE WERE NO ANOMALIES OBSERVED WITH THE BALLOON. THE BALLOON CATHETER WAS ADVANCED OVER A WIRE GUIDE THROUGH A 20FR. SHEATH, AND TOUCH UP BALLOONING OF THE MOST PROXIMAL PART OF THE AORFIX WAS BEGUN. HOWEVER, WHEN THE BALLOON WAS INFLATED CONTRAST MEDIA LEAKED FROM THE BALLOON SLOWLY. THE PHYSICIAN CONTINUED THE INFLATION, BUT AGAIN THE CONTRAST MEDIA LEAKED. SINCE THE BALLOON WAS BELIEVED TO HAVE BEEN RUPTURED, IT WAS RETRIEVED OUT OF THE BODY AND ANOTHER MANUFACTURER¿S BALLO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6962897 ↗
• MalfunctionJul 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AN INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR USING ANOTHER MANUFACTURER'S GRAFT STENT. AFTER PLACING THE STENT, THE PHYSICIAN REMOVED THE AIR FROM THE COOK CODA BALLOON CATHETER FOR TOUCH-UP. AT THIS TIME, NO PROBLEM ON THE BALLOON WAS OBSERVED, SO HE INSERTED IT INTO THE RIGHT FEMORAL THROUGH ANOTHER MANUFACTURER¿S SHEATH (20FR) AND ATTEMPTED TO INFLATE THE BALLOON WITH 10CC FOR TOUCH-UP ON THE CONTRALATERAL LEG. THE BALLOON WAS INFLATED WITHIN THE STENT GRAFT. HOWEVER THE BALLOON WOULD NOT INFLATE AND LEAKED CONTRAST MEDIA. HE REPLACED IT WITH ANOTHER CODA BALLOON CATHETER FROM A DIFFERENT LOT TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6729018 ↗
• MalfunctionJul 12, 2017Hole In Material; Leak/Splash

  WHILE USING THE BALLOON TO SEAL AND SMOOTH A WRINKLE AT THE JUNCTION OF THE MAINBODY PORTION OF A STENT, THE BALLOON LEAKED AND A PINHOLE WAS NOTED WHEN THE BALLOON WAS REMOVED. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6706765 ↗
• MalfunctionMay 2, 2017Material Rupture; Material Rupture

  IT WAS REPORTED DURING AN ENDOVASCULAR ANEURYSM REPAIR THAT A CODA BALLOON CATHETER WAS USED ON A MALE PATIENT TO SEAL THE STENT GRAFT NECK TO THE VESSEL. THE PHYSICIAN ATTEMPTED THE THIRD INFLATION OF THE BALLOON AND WHEN PERFORMING THE BALLOONING AT THE DISTAL SIDE, THE BALLOON RUPTURED. THERE WAS NO INFORMATION PROVIDED REGARDING THE DIRECTION OF THE BALLOON RUPTURE. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED THE PROCEDURE WHILE CHECKING THE (BALLOON VOLUME) CHART. A SECOND CODA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6538282 ↗