chameleon 5x40Recalls & reported problems
Av Medical Technologies Ltd · Chameleon PTA Balloon Dilatation Catheter 5x40 mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290016745016), received between May 17, 2022 and May 17, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Device problems
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
- Moisture Damage1
Patient problems
- Foreign Body In Patient1
- Unintended Radiation Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2022Fluid/Blood Leak; Moisture Damage; Detachment of Device or Device Component; Fluid/Blood Leak; Moisture Damage; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DOCTOR WAS DOING A RADIAL CEPHALIC FISTULA IN THE WRIST AREA. THE HEALTHCARE PROFESSIONAL (HCP) ASKED FOR A 5MM CHAMELEON SINCE THE HCP WOULD BE WORKING IN THE ARTERY. THEY PREPPED THE BALLOON WITH SALINE AND ADVANCED OVER A .035 MERIT LAUREATE HYDROPHILLIC GUIDE WIRE. THE HCP POSITIONED THE BALLOON UNDER FLUOROSCOPY GOING RETROGRADE USING A 6FR CORDIS SHEATH AND THEN SAW BLOOD EXITED THE BACKEND OF THE WIRE PORT. THEY DECIDED TO PULL THE CATHETER BACK. AT THAT TIME, THE HCP NOTICED UNDER FLUOROSCOPY THAT THE BALLOON HAD DETACHED FROM THE CATHETER SHAFT. THE DOCTOR THEN REMOVED THE SHAFT PORTION BUT COULD NOT GET THE REMAINING BALLOON. THE HCP GAINED ACCESS GOING ANTEGRADE, ANGIOPLASTIED THE VEIN USING A 5MM VACCESS AND TOOK AN ANGIOGRAM THROUGH THE SHEATH. THE DOCTOR THEN WENT BACK RETROGRADE AND INSERTED A 7X60 LIFESTAR STENT TO SEE IF THE HCP COULD TRAP THE BALLOON BETWEEN THE STENT AND ARTERY. THE DOCTOR SAW THE BALLOON MOVE AND DECIDED IT WOULD BE BEST IF THE PATIENT WENT TO THE OR (OPERATING ROOM) TO HAVE IT REMOVED. THE CATHETER WAS NOT REPAIRED, NO CLEANING AGENT USED ON THE DEVICE, NO TEGO UTILIZED, NO LUER ADAPTER ISSUE AND
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 14414433 ↗
Other Catheter, Angioplasty, Peripheral, Transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page