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Chameleon 9x40Recalls & reported problems

Av Medical Technologies Ltd · Chameleon PTA Balloon Dilatation Catheter 9x40 mm · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290016745054), received between Jun 3, 2021 and Jun 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

  • Burst Container or Vessel1
  • Device Fell1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 3, 2021Burst Container or Vessel; Device Fell; Burst Container or Vessel; Device Fell

    ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PHYSICIAN INFLATED THE BALLOON IN CEPHALIC ARCH USING TWO SYRINGE METHOD AND SALINE AS INFLATION FLUID, 1-2 TIMES OF INFLATION, THE BALLOON BURST LONGITUDINALLY. UPON TRYING TO REMOVE THE BALLOON FROM SHEATH (COMPETITOR¿S BRAND), THE BALLOON GOT CAUGHT IN SHEATH, AND WHEN CAUGHT, IT SNAPPED SPONTANEOUSLY JUST PROXIMAL OF BALLOON INJECTION PORT (3RD PORT). THE BALLOON REMAINED SNAPPED OFF AND STUCK IN SHEATH. IT DID NOT CAUSE ANY VESSEL TRAUMA. UPON REMOVAL OF 7FR SHEATH, THEY WERE ABLE TO PULL THE BALLOON OUT OF SHEATH FOR FURTHER INSPECTION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NEW SHEATH AND NEW BALLOON (COMPETITOR'S PRODUCT). NO ADDITIONAL MEDICAL INTERVENTION REQUIRED TO RETRIEVE THE DETACHED ITEM. THE FLUSHING WAS PERFORMED PER THE IFU (INSTRUCTIONS FOR USE). NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THEY USED A .035 GUIDE WIRE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. THERE WAS NO K

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11930431 ↗

Other Catheter, Continuous Flush devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.