Chameleon 12x40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290016745085), received between Jun 5, 2020 and Sep 29, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2021Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALLOON DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT; IT WAS UTILIZED WITH A 035 GUIDE WIRE (BARD), AND RESISTANCE ENCOUNTERED WHEN ADVANCING IT DURING FIRST ATTEMPT. THE BALLOON WAS INFLATED WITH SYRINGE, NO INFLATION FLUID WAS USED AND IT WAS DEFLATED NORMALLY. AFTER THE ANASTOMOSIS WAS CLEARED IN THE CENTRAL ARTERY, DURING REMOVAL/WITHDRAWAL OF BALLOON/WIRE FROM THE PATIENT, EXCESSIVE/ADDITIONAL FORCE WAS USED AS THERE WAS SOME SCARE TISSUE IN SURROUNDING ENTRANCE SITE AND THE CATHETER BROKE/SNAPPED AT THE SIDE HOLE (EXIT PORT). THIS WAS A SHEATH LESS PROCEDURE. THE DOCTOR HAD TO CUT DOWN AND USE SNARE TO REMOVE THE BALLOON. NO ADDITIONAL ANESTHESIA REQUIRED TO PERFORM THE CUTDOWN. ADDITIONAL SURGICAL TIME WAS NEEDED. A DIAGNOSTIC TESTING (FLUOROSCOPY) WAS DONE AS A PART OF PROCEDURE TO VERIFY IF THERE WERE NO PARTS RETAINED ON THE PATIENT¿S BODY. ALL PIECES WERE ACCOUNTED FOR AND REMOVED ON THE SAME DAY OF THE EVENT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE DEVICE WAS FLUSHED WITH NO ISSUES IDENTIFIED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12546603 ↗
• MalfunctionJun 5, 2020Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  ACCORDING TO THE REPORTER, THE 12 MM BALLOON BROKE OFF JUST ABOVE THE SIDE PORT DURING AN ANGIOPLASTY PROCEDURE ON THE PATIENT'S DIALYSIS ACCESS. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. IT WAS ALSO MENTIONED THAT NO CLEANING AGENT WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10124010 ↗