Coda G53025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002530256), received between Feb 20, 2017 and Nov 12, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• MalfunctionNov 12, 2025Material Rupture; Material Rupture

  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 23532355 ↗
• MalfunctionJun 18, 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 22288097 ↗
• MalfunctionJan 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THE PHYSICIAN PLACED A STENT GRAFT FROM ZONE 3. THE APPROACH WAS OBTAINED FROM THE RIGHT CFA. THE PHYSICIAN USED THE COMPLAINT (B)(4) FOR BALLOON TOUCH-UPS. HE DID BALLOON TOUCH-UPS AT BOTH OF THE PROXIMAL SIDE AND THE DISTAL SIDE OF THE STENT GRAFT. AFTER THAT, A TYPE IA ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY ON THE COMPETITOR'S GRAFT. THEN, THE PHYSICIAN ATTEMPTED BALLOON TOUCH-UPS AT THE PROXIMAL SIDE OF THE STENT GRAFT AGAIN. HOWEVER, THE BALLOON RUPTURED. ANOTHER (B)(4) WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE PROCEDURE ENDED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288840 ↗
• MalfunctionJun 11, 2018Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE CODA BALLOON CATHETER WOULD NOT DEFLATE AFTER BEING INFLATED INSIDE A STENT GRAFT FOR AN AORTIC ANEURYSM REPAIR PROCEDURE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7589104 ↗
• MalfunctionFeb 20, 2017Material Rupture; Material Rupture

  DURING A THORACIC ENDOVASCULAR AORTIC REPAIR PROCEDURE, A CODA BALLOON CATHETER WAS INFLATED WITH TRIPLY DILUTED CONTRAST MEDIA WITH APPROPRIATE PRESSURE AMOUNT BUT RUPTURED INSIDE THE STENT GRAFT AT THIRD INFLATION. NO ENDOLEAK WAS FOUND, SO THE PROCEDURE WAS COMPLETED WITHOUT USING ANOTHER BALLOON CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6342965 ↗