Chameleon 7x40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290016745030), received between Jan 6, 2022 and Dec 2, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALLOON WAS FLUSHED WITH SALINE THROUGH THE WIRE PORT AND THE THIRD PORT. THE BALLOON WAS INFLATED TO 6ATM WHEN IT BURST LONGITUDINAL DURING THE FIRST INFLATION. THE BALLOON WAS REMOVED THROUGH THE SHEATH, THERE WERE NO EXTRA FRAGMENTS CREATED AND NOTHING WAS FOUND TO BE LEFT BEHIND IN THE PATIENT. THIS WAS VERIFIED BY X-RAY. THE DEVICE WAS NOT REPAIRED. THERE WAS NO LEAK. SALINE WAS THE CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH CHLORAPREP AND NUMBED WITH LIDOCAINE. 6 FRENCH INTRODUCER SHEATH OF UNSPECIFIED BRAND WAS USED. GUIDEWIRE SIZE WAS .035 AND THE BRAND WAS UNSPECIFIED. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE. SALINE AND CONTRAST WERE USED AS INFLATION FLUID. FLUSHING WAS PERFORMED PER THE IFU (INSTRUCTIONS FOR USE) AND IT WAS FLUSHED WITH NO ISSUES IDENTIFIED. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. JUST THE SHEATH, GUIDEWIRE AND THE INFLATION DEVICE WERE THE OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE DOCTOR REQUESTED ANOTHER 7MM BALLOON OF THE SAME BRAND ON TH E SAME DAY A

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 15905736 ↗
• InjuryNov 10, 2022Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE 7MM BALLOON WAS PREPPED WITH SALINE AND INSERTED INTO THE PATIENT THROUGH A 6FR SHEATH. THE BALLOON WAS INFLATED USING AN INSUFFLATOR. AS THE BALLOON WAS BEING INFLATED, THE TECH NOTICED THAT BLOOD WAS FILLING THE INSUFFLATOR, INDICATING THE BALLOON HAD BROKEN. THE BALLOON WAS AT 6ATM WHEN THEY FIRST NOTICED BLOOD IN THE INSUFFLATOR. THEY REMOVED THE BALLOON FROM THE PATIENT'S ARM AND NOTICED THAT IT HAD BURST. THE BALLOON BURST ON THE FIRST INFLATION. A C-ARM X-RAY MACHINE WAS USED TO CHECK FOR FRAGMENTS IN THE PATIENT. NO FRAGMENTS WERE CREATED TO THEIR KNOWLEDGE AND THE DEVICE WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE DOCTOR WOULD USED 0.035 GUIDEWIRES IN HIS FISTULAGRAM CASES AND THEY DID NOT KNOW FOR CERTAIN WHAT MAKE OR SIZE HE USED IN THE SPECIFIC PROCEDURE. CONTRAST AND SALINE WERE USED AS INFLATION FLUID. SALINE WAS USED TO FLUSH THE BALLOON AND TO CLEAN THE DEVICE. FLUSHING WAS PERFORMED PER THE IFU (INSTRUCTIONS FOR USE). NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. A GUIDEWIRE AND SHEATH WERE USED ALONGSIDE THE DEVICE. NO RESISTANCE WAS ENCOUNTERED TO THEIR KNOWLEDGE AND THE TEC

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 15773759 ↗
• MalfunctionSep 29, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, DURING FIRST INFLATION, 8 ATM (ATMOSPHERE) PRESSURE WERE APPLIED AND THE BALLOON HAD BURST. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE, PRESTO INFLATION DEVICE WAS UTILIZED WITH THE DEVICE, AND THERE WAS NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED PER IFU (INSTRUCTION FOR USE) WITH NORMAL RESULT ACCORDING TO THE TECHNICIAN PRIOR TO INFLATING THE BALLOON AND THERE WAS NO EXCESSIVE FORCE USED TO PULL OUT THE PRODUCT. THERE WAS NO LEAK, SALINE WAS USED AS THE CLEANING AGENT ON THE DEVICE, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE PATIENT DID NOT HAVE VESSEL DAMAGE AS THE RESULT FOR THE EVENT AND THE PATIENT WAS NOT INJURED ANY WAY DUE TO THE BALLOON BURSTING. THE BALLOON WAS INFLATED USING A BARD PRESTO INFLATION DEVICE, A MIXTURE OF SALINE AND CONTRAST WAS USED TO INFLATE THE BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, THERE WERE NO TOOLS USED WHEN REMOVING THE BALLOON (THEY REMOVED THE BALLOON AS IF THE BALLOON HAD NOT BURST), ALL THE FRAGMENTS OF THE BALLOON WAS RETRIEVED AND THERE WERE NO ISSUES REMOVING THE BALLOO

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15505929 ↗
• MalfunctionJan 6, 2022Burst Container or Vessel; Leak/Splash; Detachment of Device or Device Component; Positioning Problem; Device Fell; Burst Container or Vessel; Leak/Splash; Detachment of Device or Device Component; Positioning Problem; Device Fell

  ACCORDING TO THE REPORTER, DURING PROCEDURE, A 7MM BALLOON WAS INSERTED THROUGH 7FR. (FRENCH 7) SHEATH INTO MID BASILIC VEIN AND INFLATED TO 22 ATM OF PRESSURE PER IFU (INSTRUCTION FOR USE). THE BALLOON WAS INFLATED USING AN INFLATION DEVICE AND THE INFLATION FLUID USED WAS CONTRAST AND SALINE 50-50 MIX. THE BALLOON BURST DURING FIRST INFLATION AND LEAK WAS NOTED. THE PHYSICIAN VISUALIZED THE CONTRAST SOLUTION LEAVING THE BALLOON UNDER FLUOROSCOPY. THE DOCTOR STATED THAT HE HAD DIFFICULTY REMOVING THE BALLOON FROM THE PATIENT. HE REMOVED THE 7FR. (FRENCH 7) SHEATH AND STILL HAD DIFFICULTY REMOVING THE RUPTURED BALLOON THEN EVENTUALLY HE WAS SUCCESSFUL IN REMOVING THE BALLOON. THE BALLOON WAS REMOVED SIMULTANEOUSLY (IN ONE ACTION) WITH INTRODUCER SHEATH. ALL FRAGMENTS WERE RETRIEVED AND IT WAS MENTIONED THAT THE CATHETER BROKE INTO 2 PIECES WHEN THEY WERE TRYING TO REMOVE IT FROM THE SHEATH. THE CATHETER WAS NOT REPAIRED. HE USED A BOSTON SCIENTIFIC BALLOON TO COMPLETE THE PROCEDURE AND TO RESOLVE THE PATIENT STENOSIS. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH CHLORHEXIDINE SOLUTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177996 ↗