Coda G03831Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00827002038318), received between Nov 16, 2017 and Aug 17, 2026 — classified as 2 deaths, 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50282079 ↗
• MalfunctionApr 20, 2026Material Rupture

  IT WAS REPORTED THAT THE CODA LP BALLOON CATHETER RUPTURED DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) PROCEDURE FOR AN UNKNOWN PATIENT. FOLLOWING COMPETITOR STENT GRAFT DEPLOYMENT, THE BALLOON RUPTURED IMMEDIATELY UPON INFLATION DURING PROXIMAL TOUCH-UP. A BACKUP CODA BALLOON WAS USED TO PERFORM THE PLANNED TOUCH-UP, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ENDOLEAKS. IT WAS NOTED THAT AIR REMOVAL WAS PERFORMED BY THE NURSING STAFF. 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 24924334 ↗
• DeathJan 6, 2026Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT NO LONGER MEETS THE CRITERIA FOR A REPORTABLE EVENT. SEE H11.

  Patient problems: Cardiac Arrest

  MAUDE report 23981359 ↗
• MalfunctionDec 11, 2025Difficult to Advance; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23781162 ↗
• MalfunctionDec 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED TO COOK THAT AIR LEAKED FROM A COOK CODA LP BALLOON CATHETER. THE COOK CODA LP BALLOON CATHETER WAS BEING PREPPED FOR USE FOR TOUCH UP DURING AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE. WHEN SALINE WAS INJECTED TO REMOVE AIR, THE BALLOON LEAKED. A COOK CODA LP BALLOON CATHETER FROM A DIFFERENT LOT 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 23687685 ↗
• MalfunctionOct 27, 2025Difficult to Advance; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393163 ↗
• MalfunctionSep 12, 2025Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS PROVIDED ON 10SEP2025. THE BALLOON WAS INFLATED ON THE PROXIMAL SIDE OF THE GRAFT. THERE WAS NO ANGULATION OR VESSEL CALCIFICATION AT OR NEAR THE INFLATION SITE. IMAGING, PLANNING AND SIZING, NOR PHOTOS OF THE DEVICE CAN BE PROVIDED FOR THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043053 ↗
• MalfunctionJul 28, 2025Material Rupture; Material Rupture

  COOK WAS NOTIFIED THAT A COOK CODA LP BALLOON CATHETER RUPTURED DURING AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE. A COMPETITOR'S GRAFT (28 X 70) WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND THE CUFF OF THE GRAFT WAS PLACED JUST BELOW THE KIDNEY. ANOTHER COMPETITOR'S CUFF (28 X 16 X 45) WAS PLACED ABOUT ONE TO TWO CENTIMETERS BELOW THE CUFF. AFTER PLACEMENT ON THE CONTRALATERAL AND IPSILATERAL SIDES, THE COOK CODA LP BALLOON WAS INFLATED TO 25 CC USING CONTRAST MEDIA AND APPLIED TO THE CENTRAL AREA. WHEN PRESSURE WAS APPLIED TO THE OVERLAPPING AREA OF THE CUFF AND THE MAIN BODY, THE COOK CODA LP BALLOON CATHETER RUPTURED. ANOTHER BALLOON 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 22637481 ↗
• MalfunctionJun 19, 2025Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS PROVIDED ON 10SEP2025. THERE WAS NO ANGULATION AT THE INFLATION SITE ON THE PRE-OPERATIVE SCAN OR ON THE CONTROL X-RAY AFTER POSITIONING THE BALLOON. THE THORACIC AORTA DID NOT SHOW ANY LARGE CALCIFICATIONS ON THE PRE-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN, NOR WERE THEY VISIBLE ON THE CHEST X-RAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22289719 ↗
• MalfunctionJun 18, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE CODA BALLOON CATHETER WAS UNABLE TO BE ADVANCED DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) PROCEDURE FOR AN UNKNOWN PATIENT. THE CODA WAS TO BE USED FOR TOUCH-UP; HOWEVER, IT BECAME IMPOSSIBLE TO ADVANCE INSIDE THE BODY OF THE PATIENT. THE COMPLAINT DEVICE WAS THEN REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE ON THE OTHER SIDE, BUT STRONG RESISTANCE WAS STILL FELT. THERE WAS CONCERN BY THE PHYSICIAN THAT CONTINUED ATTEMPTS WOULD MAKE THE CATHETER IMPOSSIBLE TO REMOVE, SO THE USE OF THE CODA WAS STOPPED. A BALLOON CATHETER FROM ANOTHER MANUFACTURER WAS USED TO SUCCESSFULLY TO COMPLETE THE PROCEDURE. 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 22288140 ↗
• MalfunctionApr 18, 2025Difficult to Advance; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865663 ↗
• MalfunctionMar 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CODA LP BALLOON CATHETER BURST AS IT WAS BEING INFLATED DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE ON AN UNKNOWN PATIENT. A NEW LIKE DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS A RESULT OF THE BALLOON RUPTURE, THE PATIENT SPENT ADDITIONAL TIME UNDER ANESTHESIA. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559021 ↗
• MalfunctionJan 13, 2025Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT HAIR-LIKE FOREIGN MATTER WAS DISCOVERED WITHIN THE SEALED PACKAGING OF A CODA LP BALLOON CATHETER PRIOR TO USE IN A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE ON AN UNKNOWN PATIENT. THERE WAS NO NEED FOR BALLOONING DURING THE PROCEDURE, SO A REPLACEMENT BALLOON CATHETER WAS NOT REQUIRED. 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 21146262 ↗
• MalfunctionJan 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CODA LP BALLOON CATHETER RUPTURED DURING A PROCEDURE. A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2019 AND HAD ANOTHER MANUFACTURER'S STENT GRAFT IMPLANTED. THE COOK CODA BALLOON WAS USED FOR TOUCH UPS AFTER THE EVAR. UPON THE FIRST INFLATION, THE BALLOON RUPTURED. ANOTHER CODA BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING EVENT DETAILS BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539911 ↗
• MalfunctionJul 16, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8795839 ↗
• MalfunctionApr 24, 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 8546919 ↗
• DeathDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED ON (B)(6) 2018, A (B)(6)-YEAR OLD FEMALE PATIENT UNDERWENT STENT GRAFT PLACEMENT TO TREAT THORACIC AORTIC ANEURYSM (TAA) / ABDOMINAL AORTIC ANEURYSM (AAA). AFTER ANOTHER MANUFACTURER'S STENT GRAFT WAS PLACED BELOW RENAL ARTERY, TOUCH-UP BALLOONING WAS PERFORMED WITH CODA BALLOON. THE PROXIMAL PLATINUM MARKER OF THE CODA BALLOON WAS LOCATED AT THE PROXIMAL END OF THE STENT GRAFT DURING INFLATION. NO PART OF THE BALLOON WAS OUTSIDE OF THE GRAFT DURING INFLATION. AT THIS POINT, THE INFRARENAL ABDOMINAL AORTA RUPTURED BLOOD INFUSION WAS PERFORMED, BUT THE PATIENT'S HEMODYNAMIC STABILITY WAS NOT RECOVERED. THEY ATTEMPTED TO PLACE ANOTHER STENT GRAFT WAS ATTEMPTED TO TREAT THE ABDOMINAL AORTA DAMAGE, BUT THIS ATTEMPT FAILED. THEREFORE, THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL REPAIR. THE PATIENT WAS NOT RECOVERED, AND DECEASED. AS REPORTED, THE PATIENT HAS SEVERE CALCIFICATION FROM THE ABDOMINAL AORTA THROUGH THE ILIAC ARTERY. THE BALLOON WAS INFLATED USING A 20CC SYRINGE. HOWEVER, THE VOLUME/PRESSURE USED DURING INFLATION IS NOT KNOWN. IT IS NOT KNOWN IF THE PATIENT WAS ON ANTICOAGULANTS. AN AUTOPSY WILL NOT BE PERFORMED. THE DEVICE WILL NOT BE RETURNED TO

  Patient problems: Death

  MAUDE report 8126988 ↗
• InjuryNov 20, 2018Material Separation; Material Separation

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 8090014 ↗
• MalfunctionSep 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH OTHER MANUFACTURERS' MAIN BODY AND LEG GRAFT STENTS. AFTER PLACING THESE STENT GRAFTS, THE CODA LP BALLOON CATHETER WAS USED FOR BALLOON TOUCH-UP. WHEN THE USER INFLATED THE BALLOON IN ORDER TO PERFORM TOUCH-UP IN THE CONNECTION BETWEEN THE MAINBODY AND ILIAC LEG, THE BALLOON RUPTURED. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER CODA LP BALLOON CATHETER OF A DIFFERENT LOT NUMBER. THE PROCEDURE WAS COMPLETED AFTER SUCCESSFUL BALLOON TOUCH-UP WITH THE REPLACEMENT DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PHYSICIAN COMMENTED, ¿I DID NOT CHECK THE VOLUME SPECIFICALLY WHEN INFLATING THE BALLOON THOUGH, I INFLATED IT AS USUAL. I THINK THAT THE BALLOON MIGHT HAVE BEEN CAUGHT ON THE PROXIMAL EDGE OF THE OTHER MANUFACTURER'S LEG GRAFT.¿ THE DEVICE WILL NOT BE RETURNED DUE TO INFECTIOUS DISEASE (HCV). NO IMAGE OR NO PHOTO OF THE DEVICE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898624 ↗
• MalfunctionAug 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THE CUSTOMER SELECTED A CODA LP BALLOON CATHETER FOR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR USING ANOTHER MANUFACTURER'S STENT GRAFT. AFTER THE DOCTOR PLACED THE OTHER MANUFACTURER'S GRAFT, HE TESTED THE BALLOON PRIOR TO INSERTION INTO THE PATIENT AND FELT THE BALLOON WAS TIGHTER/STIFFER THAN USUAL BUT PROCEEDED TO USE THE DEVICE ON THE PATIENT. THE BALLOON RUPTURED AT THE FIRST INFLATION. HE REPLACED IT WITH ANOTHER CODA BALLOON CATHETER TO COMPLETE THE PROCEDURE. NO RESISTANCE WAS NOTICED UPON INSERTION OF THE BALLOON IN THE PATIENT. AN 18 FRENCH SHEATH OF UNKNOWN MODEL WAS USED WITH THE BALLOON. THERE WAS SLIGHT CALCIFICATION PRESENT IN THE VESSELS CONTAINING THE GRAFTS. THE BALLOON WAS INFLATED TO APPROXIMATELY 2 ATM IN THE PROXIMAL NECK OF THE GRAFT. THE BALLOON STARTING INFLATING AS USUAL AND RUPTURED WITHOUT RESISTANCE DURING INFLATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7814151 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT IMAGING OF THE PROCEDURE IS NOT AVAILABLE. THE PLANNING AND SIZING SHEET IS ALSO NOT AVAILABLE. THE RESIDENT APPEARED TO BE IN A RUSH AND DID NOT CONFIRM THAT THE BALLOON WAS FULLY DEFLATED BEFORE REMOVING IT FROM THE GRAFT. THIS DID NOT APPEAR TO HAVE ANYTHING TO DO WITH THE CODA BALLOON BUT WAS A TECHNICAL FAILURE BY THE OPERATOR.

  Patient problems: No Code Available

  MAUDE report 7655621 ↗
• MalfunctionJun 12, 2018Detachment Of Device Component

  THE COMPLAINANT REPORTED THAT THE BALLOONS (QUANTITY 2) ON THE CODA LP BALLOON CATHETER POPPED DURING INFLATION FOR AN EVAR (ENDOVASCULAR ANEURYSM REPAIR). 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 7591230 ↗
• MalfunctionJun 11, 2018Material Rupture

  THE COMPLAINANT REPORTED THAT THE BALLOONS (QUANTITY 2) ON THE CODA LP BALLOON CATHETER POPPED DURING INFLATION FOR AN EVAR (ENDOVASCULAR ANEURYSM REPAIR). 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 7589600 ↗
• MalfunctionMar 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE CODA BALLOON CATHETER WAS USED TO PERFORM TOUCH-UP BALLOONING, HOWEVER DURING USE THE BALLOON RUPTURED. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7324729 ↗
• MalfunctionMar 8, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN THE PHYSICIAN WAS PREPARING DEVICES FOR THE ENDOVASCULAR ANEURYSM REPAIR (EVAR), AN UNIDENTIFIED FOREIGN MATTER WAS FOUND IN THE PACKAGE CONTAINING THE CODA LP BALLOON CATHETER. NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7324636 ↗