Chameleon 10x40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290016745061), received between Jun 5, 2020 and Jun 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2020Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, THE BALLOON WAS BEING USED TO TREAT A CENTRAL STENOSIS, THE BALLOON WAS INDICATED FOR A RATED BURST PRESSURE OF 14ATM, BUT THE PHYSICIAN SAID THAT ON THE SECOND ANGIOPLASTY THE BALLOON RUPTURED AT 10ATM. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, NO DAMAGE ON THE BOX OR PACKAGING, ALL PIECES WERE RETRIEVED IN THE PATIENTS BODY, FLUOROSCOPY WAS DONE TO CONFIRM ALL PIECES WERE RETRIEVED, INTRODUCER SHEATH WAS USED TO ALLOW THE BALLOON TO BE INTRODUCED, NO TREATMENT/INTERVENTION WAS REQUIRED AS A RESULT OF BALLOON BURST, THERE WAS NO HARM TO THE PATIENT DUE TO THE RUPTURE. THEY SWITCHED OUT BALLOONS TO COMPLETE THE PROCEDURE (ANGIOPLASTY).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10124043 ↗