Chameleon CH12-40-75USRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521812321), received between Sep 8, 2022 and Jan 26, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 19, 2024Open, Classified

   Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.

   Z-0257-2025 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionJan 26, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO THE RIGHT FOREARM AVF (ARTERIOVENOUS FISTULA). THE CATHETER WAS USED TO TREAT STENOSIS OF THE INNOMINATE VEIN (90% OCCLUDED), THE SVC (SUPERIOR VENA CAVA) (70% OCCLUDED) AND THE CEPHALIC VEIN (70% OCCLUDED). THE BALLOON WAS INFLATED THREE TIMES TO 8 ATMS, ONCE IN EACH AREA LISTED ABOVE. UPON REMOVAL OF THE BALLOON FROM THE PATIENT VEIN, IT GOT STUCK AND BROKE IN THE SHEATH. THERE WERE NO ISSUES WITH PRIOR WITH INFLATING AND DEFLATING THE BALLOON. INFLATION DEVICE FROM COMPETITOR WAS USED TO INFLATE THE BALLOON. THE BALLOON WAS DETACHED FROM THE CATHETER UPON REMOVAL, AND IT WAS STUCK INSIDE THE SHEATH. THE CUSTOMER USED A COMPETITOR'S SHEATH WITH INT .035 GUIDEWIRE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO SIGNIFICANT FORCED WAS USED PER THE CUSTOMER. NO STENT WAS USED TO PASS THE DEVICE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591561 ↗
• MalfunctionDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS PULLED OUT OF THE PACKAGING, THE CATHETER SHAFT HAD SPLIT INTO TWO PIECES. THERE WAS NO OBVIOUS DAMAGE TO THE PACKAGING AND/OR THE CATHETER BEFOREHAND. THE DEVICE'S BOX CAME IN INTACT AND THE STERILE BARRIER WAS INTACT. BESIDES THE REPORTED ISSUE, THERE WAS NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NO DIFFICULTY WHEN PULLING THE DEVICE OUT OF THE PACKAGING. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE, AND THE DETACHMENT WAS SEEMINGLY SPONTANEOUS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TO RESOLVE THE ISSUE, A NEW PRODUCT WAS PROVIDED TO THE CUSTOMER FROM THE TRUNK STOCK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302504 ↗
• MalfunctionJun 30, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE FIRST BALLOON (SIZE 12MILLIMETERX40MMX75CENTIMETER) WAS DEFLATED AND BECAME HUNG UP IN AN INTRODUCER SHEATH AND ACTUALLY SHEARED OFF (UNCERTAIN IF COMPLETELY DETACHED) ABOUT 1.5 INCHES ABOVE THE SHEATH. THEY HAD TO USE ANOTHER INTRODUCER SHEATH TO FISH IT OUT. THE OTHER BALLOON (SIZE 10X4) WAS WORKING FINE AND THEN TAKEN OUT OF THE PATIENT DURING A DECLOT CASE. WHEN THE BALLOON WAS REINSERTED, THE BALLOON WAS NOT ABLE TO OPEN ONCE INSIDE THE PATIENT. THEY REMOVED THE BALLOON AND IT APPEARED THAT PART OF THE BALLOON WAS GETTING HUNG UP ON ITSELF ON THE INJECTION PORT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER CONNECTOR ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. INTRODUCER SHEATH (FRENCH 7), CONTRAST, SALINE AND 0.35 GUIDEWIRE WERE UTILIZED WITH THE DEVICE. FLUSHING WAS DONE AS PER IFU (INSTRUCTION FOR USE) AND HAD A NORMAL/GOOD OUTCOME. THERE WAS NO REPORTED CLEANING AGENT USED ON THE DEVICE. THE BALLOON WAS INFLATED USING A SYRINGE AND STANDARD INFLATION FLUID WAS USED. A MAXIMUM INFLATION PRESSURE WAS APPLIED WHEN IT WAS DETERMINED THAT THERE WAS INFLATION DIFFICULTIES. THE DEVICE PASSED THROUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240871 ↗
• MalfunctionDec 29, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DOCTOR INFLATED THE BALLOON SUCCESSFULLY FOR 2 TIMES AND HELD THE PRESSURE AT 14 ATMS (ATMOSPHERE) FOR 2 MINUTES. THE AVF (ARTERIOVENOUS FISTULA) WAS OCCLUDED FOR 90% AT ARCH, 70-80% INNOMINATE AND 80% FOR CV (CEPHALIC VEIN). ON THE THIRD TIME OF INFLATING THE BALLOON, IT WAS RUPTURED. THE HCP (HEALTHCARE PROFESSIONAL) WORKED TO REMOVE THE BALLOON AND THEY USED A MERIT 7 FR SHEATH. THE BALLOON GOT STUCK IN THE SHEATH AND BROKE OFF THE SHAFT WHILE TRYING TO PULL IT BACK OUT OF THE SHEATH. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED PRIOR TO USING THE BALLOON, NO DEFECTS WERE OBSERVED ON THE PRODUCT, AND FLUSHING WAS DONE PER IFU (INSTRUCTION FOR USE) AND THE RESULT WAS NORMAL. THE DEVICE WAS NOT REPAIRED, THERE WAS NO CLEANING AGENT USED ON THE DEVICE PRIOR TO USE, TEGO WAS NOT UTILIZED, AND CHLORAPREP SKIN PREP WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WERE PRODUCTS UTILIZED WITH THE DEVICE (GUIDEWIRE, 7FR SHEATH, INSUFFLATOR), THE BALLOON WAS INFLATED USING A INSUFFLATOR (INFLATION DEVICE 30 ATM/BAR, BASIX COMPAK TM, VERSION L), THE INFLATION FLUID USED WAS A MIX OF SALIN E AND CONTRAST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075472 ↗
• MalfunctionSep 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER ANGIOPLASY, THE TECH REMOVED THE BALLOON FROM THE SHEATH AND THE BACK END OF THE SPLIT APART FROM THE CATHETER. IT WAS STATED THAT THE LUER ADAPTER DETACHED (LUER ADAPTER AND BACK END OF THE BALLOON CAME APART FROM THE CATHETER). THERE WAS NO LEAK. THE INSERTION SITE TREATED WITH PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED AND THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379751 ↗