Coda G23773Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002237735), received between Oct 23, 2017 and Jul 14, 2025 — classified as 1 injury, 6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Use of Device Problem; Use of Device Problem

  COOK WAS NOTIFIED THAT A RUPTURE OF THE ABDOMINAL AORTA OCCURRED AFTER BALLOONING WITH A COOK CODA BALLOON. THE INDICATION FOR THE ELECTIVE PROCEDURE WAS A POST-DISSECTING THORACIC ABDOMINAL AORTIC ANEURYSM (TAAA) TYPE I EXTENT, CRAWFORD CLASSIFICATION. A RESCUE REPAIR HAD BEEN PERFORMED AFTER PRIOR OPEN REPAIR WITH A THORACIC SURGICAL GRAFT FOR A TYPE A DISSECTION. PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) WITH CONTRAST IMAGING WAS COMPLETED ON (B)(6) 2024 (151 DAYS PRIOR TO THE PROCEDURE). THE BILATERAL COMMON ILIAC AND INTERNAL ILIAC ARTERIES WERE PATENT. THE BILATERAL VERTEBRAL ARTERIES WERE PATENT. THE AORTIC VALVE WAS NATIVE. THE MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTER LINE WAS 68 MM. THE INTENDED PROXIMAL LANDING ZONE WAS ZONE 2: LEFT COMMON CAROTID TO LEFT SUBCLAVIAN ARTERY. THE INTENDED DISTAL LANDING ZONE WAS ZONE 5: MID DESCENDING AORTA TO CELIAC ARTERY. THE PATIENT UNDERWENT THE FIRST PROCEDURE OF THE STAGED PROCEDURES ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA) AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS ACHIEVED IN THE RIGHT AND LEFT FEMORAL ARTERIES. THE LEFT FEMORAL VEIN WAS ACCESSED FOR CARDIAC RAP

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Paraplegia; Shock; Spinal Cord Injury

  MAUDE report 22500445 ↗
• MalfunctionApr 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CODA BALLOON CATHETER RUPTURED. DURING AN OPERATION ON (B)(6) 2025 AT 14:23 HOURS, THE BALLOON OF THE CODA DEVICE BURST DURING INFLATION IN THE PATIENT'S AORTA. A SECOND CODA FROM THE SAME LOT WAS OBTAINED AND EXPERIENCED THE SAME FAILURE. FINALLY, A COMPETITOR'S 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884358 ↗
• MalfunctionOct 24, 2019Material Rupture; Material Rupture

  NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235304 ↗
• MalfunctionSep 10, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A "STRANGE PARTICLE" WAS FOUND INSIDE THE PRIMARY PACKAGING OF A CODA BALLOON CATHETER. NO PATIENT CONTACT WAS MADE AS THE ISSUE WAS NOTICED BEFORE THE PRODUCT WAS OPENED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 8983198 ↗
• MalfunctionJul 16, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Patient Involvement

  MAUDE report 8795886 ↗
• MalfunctionJun 13, 2018Material Rupture

  IT WAS REPORTED THAT DURING THE TEVAR PROCEDURE, WHEN THE CODA BALLOON CATHETER WAS USED, THE BALLOON RUPTURED AFTER INFLATION. THERE WAS A DELAY REPORTED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7597105 ↗
• MalfunctionOct 23, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE DISTRIBUTOR REPORTED THAT DURING INSPECTION OF THE CODA BALLOON CATHETER IT WAS OBSERVED THAT THERE WAS A HAIR INSIDE THE PRIMARY PACKAGE. THIS PRODUCT WAS NOT USED ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6969829 ↗