Chameleon CH08-40-75USRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521812291), received between Aug 19, 2022 and Jun 19, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Dec 17, 2021Open, Classified

   The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.

   Z-0557-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryJun 19, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ACCORDING TO THE REPORTER, THE BALLOON CAME APART WITH A SECTION LODGED IN A PATIENT¿S ARTERY.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19571045 ↗
• MalfunctionNov 9, 2023Difficult 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 PROVIDER WAS ATTEMPTING TO REMOVE THE BALLOON FROM THE 6FR SHEATH (MERIT PRELUDE), AND THE BALLOON BECAME STUCK. THE PROVIDER CONTINUED TO PULL, AND THE BALLOON SHAFT STRETCHED TO THE POINT OF BREAKING, LEAVING THE BALLOON IN THE SHEATH IN COMPLETE DISCONNECTION OF THE CATHETER INTO TWO SEPARATE PIECES AND WAS LEFT INSIDE THE SHEATH. THERE WERE NO PIECES FELL IN THE PATIENT'S BODY. IT WAS ALSO STATED THAT THE ISSUE ENCOUNTERED AFTER BALLOON INFLATION, BALLOON WAS FULLY DEFLATED AND WAS DETACHED FROM THE CATHETER. THE BALLOON WAS INFLATED USING INFLATION DEVICE ¿BARD PRESTO¿. THERE WAS NO LEAK AND NO ISSUE WITH THE LUER ADAPTER. THE CATHETER WAS NOT REPAIRED. THERE WAS NOTHING UNUSUAL OBSERVE ON THE PRODUCT PRIOR TO USE AND THEREWERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE ISSUE WAS OBSERVED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE PRODUCT AND THE INSERTION SITE WAS NOT TREATED WITH PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONEWITH NO ISSUES IDENTIFIED. THE SHEATH AND BALLOON WERE REMOVED TOGETHER AS REMEDIAL ACTION, AND NEW SHEATH AND DIFFERENT BALLOON WERE PLACED AT SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107158 ↗
• MalfunctionOct 3, 2023Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  ACCORDING TO THE REPORTER, THE FIRST TIME THE DEVICE WAS USED AT A NOMINAL VALUE OF 16 ATMOSPHERIC PRESSURE, AND THE SECOND TIME IT WAS USED AT 22 ATMOSPHERES, AND AFTER INFLATING THE BALLOON IN THE PATIENT, THE BALLOON RUPTURED DUE TO A LONGITUDINAL CRACK AFTER 20 SECONDS. IT WAS NOTICED THAT THE PRESSURE HAD DECREASED. THERE WAS NO LEAK. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER PARTICULAR DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO PARTICULAR PRODUCTS UTILIZED WITH THE DEVICE. IT WAS STATED THAT 6 FRENCH (FR) AND 11 CENTIMETERS (CM) OF COMPETITOR'S INTRODUCER SHEATH WAS USED, AND A 0.035 COMPETITOR'S GUIDEWIRE WAS USED. AN UNKNOWN INFLATOR WAS USED TO INFLATE THE BALLOON, AND THE INFLATION FLUID USED COULD NOT BE CONFIRMED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT COULD NOT BE CONFIRMED IF THERE WAS RESISTANCE ENCOUNTERED WHEN THE DEVICE WAS ADVANCED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE BALLOON HAD BEEN COLLECTED. IT WAS ONLY A RUPTURE AND DID NOT BECOME A PIECE. THE BALLOON WAS REMOVED WHEN IT WAS PULLED OUT WITH THE SHEATH I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865726 ↗
• MalfunctionAug 19, 2022Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  ACCORDING TO THE REPORTER, DURING ADVANCEMENT THROUGH THE SHEATH, BALLOON AND SHAFT WERE BROKEN. BALLOON WAS STILL INTACT. THE CATHETER WAS NOT REPAIRED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS PERFORMED. INTRODUCER SHEATH WAS USED. PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262656 ↗