Coda G03832Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002038325), received between Jul 16, 2018 and Aug 12, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Material Rupture; Material Rupture

  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 22786255 ↗
• MalfunctionMar 12, 2025Difficult to Advance; Difficult to Advance

  ADDITIONAL INFORMATION WAS PROVIDED ON 10MAR2025. IMAGING AND PROCEDURAL NOTES FOR THE EVENT ARE NOT AVAILABLE. THE COOK CODA BALLOON WAS THE ONLY DEVICE THAT EXPERIENCED DIFFICULT ADVANCEMENT OR DIFFICULT REMOVAL IN THE PROCEDURE. ALTHOUGH THERE WAS RESISTANCE, THE DELIVERY WAS ACHIEVED, AND THE PROCEDURE WAS COMPLETED WITH A TOUCH-UP USING A CODA BALLOON. WHEN ASKED "WAS THE DEVICE DIFFICULT TO ADVANCE THROUGH THE SHEATH OR THROUGH THE PATIENT'S VESSELS, THE RESPONSE WAS "YES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587353 ↗
• MalfunctionMar 12, 2025Difficult to Advance; Difficult to Advance

  ADDITIONAL INFORMATION WAS PROVIDED ON 10MAR2025. IMAGING AND PROCEDURAL NOTES FOR THE EVENT ARE NOT AVAILABLE. THE COOK CODA BALLOON WAS THE ONLY DEVICE THAT EXPERIENCED DIFFICULT ADVANCEMENT OR DIFFICULT REMOVAL IN THE PROCEDURE. ALTHOUGH THERE WAS RESISTANCE, THE DELIVERY WAS ACHIEVED, AND THE PROCEDURE WAS COMPLETED WITH A TOUCH-UP USING A CODA BALLOON. WHEN ASKED "WAS THE DEVICE DIFFICULT TO ADVANCE THROUGH THE SHEATH OR THROUGH THE PATIENT'S VESSELS, THE RESPONSE WAS "YES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587290 ↗
• MalfunctionMar 12, 2025Difficult to Advance; Difficult to Advance

  ADDITIONAL INFORMATION WAS PROVIDED ON 10MAR2025. IMAGING FOR THE EVENT IS NOT AVAILABLE. PROCEDURAL NOTES FOR THE EVENT ARE NOT AVAILABLE. NONE OF THE DEVICES EXPERIENCED DIFFICULT ADVANCEMENT OR REMOVAL DURING THE PROCEDURE. WHEN ASKED "WAS THE DEVICE DIFFICULT TO ADVANCE THROUGH THE SHEATH OR THROUGH THE PATIENT'S VESSELS, THE RESPONSE WAS "YES." THE DEVICE WAS NOT DIFFICULT TO REMOVE FROM THE PATIENT. THE PHYSICIAN ALSO ATTEMPTED TO USE THE SAME DEVICE ON THE OTHER SIDE BUT CONFIRMED THAT DELIVERY WAS DIFFICULT. A BALLOON FROM ANOTHER MANUFACTURER WAS USED AND DELIVERY WAS COMPLETED ON BOTH SIDES WITHOUT RESISTANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587255 ↗
• MalfunctionJul 25, 2023Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2023. PRIOR TO INSERTION OF THE DEVICE INTO THE PATIENT, THE DEVICE WAS PREPPED BY FLUSHING THE CATHETER AND ATTEMPTING TO INFLATE THE BALLOON. THE BALLOON "DID NOT INFLATE ENOUGH." NO OBVIOUS HOLES IN THE BALLOON WERE DETECTED. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED BY USING A COMPETITOR'S BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388723 ↗
• MalfunctionJul 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO CODA LP BALLOONS RUPTURED DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE. THE PATIENT WAS CONSIDERED SUITABLE FOR THIS PROCEDURE, ALTHOUGH HAD VESSEL CALCIFICATION AND SLIGHT ANGULATION AT OR NEAR THE INFLATION SITE. AFTER A STENT GRAFT WAS PLACED BY RIGHT APPROACH, BALLOONING WAS PERFORMED IN THE PROXIMAL SITE OF THE STENT GRAFT. THE FIRST BALLOON RUPTURED "ON THE DISTAL SIDE OF THE BALLOON" AFTER THE SECOND OR THIRD BALLOONING. THE SECOND BALLOON ALSO RUPTURED AT THE PROXIMAL SITE OF THE STENT GRAFT, THIS TIME ON FIRST BALLOONING. THE CONTRAST TO SALINE RATIO FOR INFLATION OF THE BALLOONS WAS 10:20 AND THE VOLUME USED FOR BOTH DEVICES WAS APPROXIMATELY 20/25 ML. NO INFLATION DEVICE WAS UTILIZED FOR INFLATION OF EITHER BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S BALLOON DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE FIRST BALLOON THAT RUPTURED IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER (B)(6) (THIS REPORT). THE SECOND BALLOON THAT RUPTURED IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075124 ↗
• MalfunctionJul 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO CODA LP BALLOONS RUPTURED DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE. THE PATIENT WAS CONSIDERED SUITABLE FOR THIS PROCEDURE, ALTHOUGH HAD VESSEL CALCIFICATION AND SLIGHT ANGULATION AT OR NEAR THE INFLATION SITE. AFTER A STENT GRAFT WAS PLACED BY RIGHT APPROACH, BALLOONING WAS PERFORMED IN THE PROXIMAL SITE OF THE STENT GRAFT. THE FIRST BALLOON RUPTURED "ON THE DISTAL SIDE OF THE BALLOON" AFTER THE SECOND OR THIRD BALLOONING. THE SECOND BALLOON ALSO RUPTURED AT THE PROXIMAL SITE OF THE STENT GRAFT, THIS TIME ON FIRST BALLOONING. THE CONTRAST TO SALINE RATIO FOR INFLATION OF THE BALLOONS WAS 10:20 AND THE VOLUME USED FOR BOTH DEVICES WAS APPROXIMATELY 20/25 ML. NO INFLATION DEVICE WAS UTILIZED FOR INFLATION OF EITHER BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S BALLOON DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE FIRST BALLOON THAT RUPTURED IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER 368686 THE SECOND BALLOON THAT RUPTURED IS CAPTURED IN THE REPORT WITH PATIENT IDENTIFIER 368678 (THIS REPORT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074812 ↗
• MalfunctionAug 24, 2018Material Rupture; Material Rupture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7814413 ↗
• MalfunctionJul 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) AGAINST AN ABDOMINAL AORTIC ANEURYSM (AAA) WAS PERFORMED. THERE WERE NO SPECIFIC ANATOMICAL PROBLEMS IN THE PATIENT. AFTER ANOTHER MANUFACTURER'S GRAFT WAS PLACED IN THE TARGET POSITION, TOUCH-UP BALLOONING WAS CONDUCTED WITH THE CODA LP BALLOON CATHETER. THE BALLOON RUPTURED WHEN THE PHYSICIAN ATTEMPTED TO DILATE THE JUNCTION OF THE MAIN BODY AND THE LEG WITH THE CODA. ANOTHER CODA LP BALLOON CATHETER OF THE SAME LOT NUMBER WAS USED AND THE BALLOONING WAS PERFORMED WITHOUT PROBLEMS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN COMMENTED THAT THE EXACT AMOUNT OF INFLATION FLUID WAS NOT KNOWN. IT IS POSSIBLE THAT THE BALLOON GOT STUCK ON THE PROXIMAL EDGE OF THE OTHER MANUFACTURER'S GRAFT CAUSING IT TO RUPTURE. AS REPORTED, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691264 ↗