Chameleon CH07-40-75USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521812284), received between Jun 27, 2022 and Aug 6, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Detachment of Device or Device Component; Infusion or Flow Problem; Detachment of Device or Device Component; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE ON A PATIENT WITH A STENOSIS IN THE LAUNCH AREA OF THE GRAFT, THE PHYSICIAN FOUND RESISTANCE WHILE INJECTING CONTRAST MEDIA FROM THE THIRD PORT AND REMOVED THE WIRE TO COMPLETE THE INJECTION. WHEN THEY REINSERTED THE WIRE AND TRIED TO REMOVE THE CATHETER, THE BALLOON WAS DETACHED. THEY FOUND IT ATTACHED TO THE WIRE. THE DETACHMENT WAS SPONTANEOUS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO CLEANING AGENT WAS USED ON THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. AN INTRODUCER SHEATH WAS USED. A 0.035 GUIDE WIRE WAS USED. FLUSHING WAS NOT PERFORMED. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE. SALINE AND CONTRAST WERE THE INFLATION FLUIDS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. A SNARE WAS USED AS AN INTERVENTION TO RETRIEVE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917891 ↗
• MalfunctionMar 19, 2024Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, A 7MMX40MM BALLOON CATHETER WAS UNABLE TO BE REMOVED THROUGH A 6 FR. (FRENCH) SHEATH. THE BALLOON DETACHED FROM THE CATHETER AND WAS STUCK IN THE SHEATH WHEN TRYING TO BE REMOVED FROM THE PATIENT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932815 ↗
• MalfunctionJun 29, 2023Burst Container or Vessel; Material Integrity Problem; Positioning Problem; Burst Container or Vessel; Material Integrity Problem; Positioning Problem

  ACCORDING TO THE REPORTER, WHEN ADVANCING THE DEVICE ON FIRST ATTEMPT, RESISTANCE ENCOUNTERED. AFTER FIRST INFLATION UP TO 14 ATMS ( ATMOSPHERE), THE PRODUCT'S BALLOON HAD BURST, HAD TORN BUT THE BALLOON DID NOT COMPLETELY SEPARATE FROM THE SHAFT AND NO PORTION OF DEVICE FELL IN PATIENT. IT WAS ALSO STATED THAT THE LUER CONNECTOR WAS WEAK AND HAD TORN. 7 FR COMPETITOR'S INTRODUCER SHEATH WAS USED. THE SIZE OF GUIDEWIRE WAS .035. NO EXCESSIVE FORCE USED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE BALLOON WAS INFLATED BY INFLATION DEVICE. FLUSHING WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO CLEANING AGENT USED ON THE DEVICE. THEY REMOVED OR PULLED OUT THE PRODUCT FROM PATIENT THROUGH THE SHEATH BEFORE TOO MUCH BLOOD LOSS AS REMEDIAL ACTION TO ADDRESS THE ISSUE. THE PROCEDURE WAS COMPLETED WITH COMPETITOR'S BALLOON. THERE WAS UNSPECIFIED AMOUNT OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO ADDITIONAL TREATMENTS/INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227647 ↗
• InjuryMay 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALLOON SEPARATED FROM THE CATHETER SHAFT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THE CATHETER WAS NOT REPAIRED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE PHYSICIAN ADDED THREE HOURS TO THE CASE TO FISH OUT WITH FOGARTY. THERE WAS NO HARM DONE TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16962864 ↗
• MalfunctionNov 8, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALLOON BURST AT 18-20 ATMS (ATMOSPHERE). THE DEVICE WAS NOT REPAIRED, THERE WAS NO LEAK, SALINE WAS USED AS THE CLEANING AGENT ON THE DEVICE, TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMEN. THE DEVICE WAS REPLACED BY ANOTHER COMPETITOR'S PRODUCT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752978 ↗
• InjuryJun 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT WAS 64 YEARS OLD AND ON HEMODIALYSIS AT THE DCI ((B)(4)) CARONDELET DIALYSIS UNIT. THE PATIENT HAD A LEFT UPPER ARM LOOP BRACHIOBASILIC GRAFT WITH MEDIAN VEIN CONFIGURATION. THE PATIENT CAME IN FOR INCREASED BLEEDING FROM THE GRAFT. THE PATIENT HAD AN ANGIOPLASTY OF THE VENOUS END OF THE GRAFT PERFORMED BY KANSAS CITY INTERVENTIONAL GROUP. IT WAS SAID THAT THE PATIENT WAS INFORMED AND AN INFORMED CONSENT FOR THE PROCEDURE WAS OBTAINED. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM. LEFT ARM WAS PREPPED AND DRAPED. LIDOCAINE 1% WAS INJECTED PROXIMALLY AND CANNULATION OF THE GRAFT WAS PERFORMED USING A 21-GAUGE MICRO PUNCTURE NEEDLE. A GUIDEWIRE WAS PLACED ACROSS THE NEEDLE AND A 5-FRENCH SHEATH WAS ADVANCED OVER THE WIRE. INTRODUCER AND THE WIRE WERE REMOVED. SHEATH WAS FLUSHED WITH SALINE. GOOD BLOOD FLOW WAS OBTAINED. DILUTED DYE WAS INJECTED INTO THE FISTULA DEMONSTRATED WIDELY PATENT FISTULA PROXIMALLY IN THE DISTAL END OF THE ARTERIAL LIMB AND NOTICED A PSEUDOANEURYSM IN THE DISTAL PORTION OF THE GRAFT CORRESPONDING TO FREQUENT CANNULATION IN THE SAME SITE WITH RESIDUAL THROMBUS IN THE ANEURYSM. THE DISTAL END OF THE ANEURYSM HAD A MILD

  Patient problems: Aneurysm; Foreign Body In Patient; Pseudoaneurysm; Stenosis; Unintended Radiation Exposure

  MAUDE report 14836077 ↗