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Chameleon CH05-40-75USRecalls & reported problems

Mozarc Medical US LLC · PTA Balloon Catheter with Injection Port · Class 2

All models of Chameleon (7)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521812260), received between Sep 7, 2023 and Sep 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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

Device problems

  • Burst Container or Vessel1

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.

  • MalfunctionSep 7, 2023Burst Container or Vessel; Burst Container or Vessel

    ACCORDING TO THE REPORTER, DURING THE FIRST INFLATION AT 2 ATM (ATMOSPHERE),THE BALLOON BURST LONGITUDINALLY. THE BALLOON LOOKED AND ACTED NORMAL PRIOR TO INFLATION. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PRODUCT SEPARATED INTO TWO OR MULTIPLE SEPARATE PIECES. HOWEVER, ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. ASSUMED A 6FR INTRODUCER SHEATH WAS USED. NO EXCESSIVE FORCE WAS USED. THE CATHETER WAS NOT REPAIRED. SALINE AND CONTRAST MIX WAS THE CLEANING AGENTS USED ON THE DEVICE. THE BALLOON WAS INFLATED BY INFLATION DEVICE (MAKE AND MODEL) BARD PRESTO. FLUSHING WAS PERFORMED PER INSTRUCTION PER USE, AND NO ISSUES WERE IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WERE NO ADDITIONAL TREATMENTS OR INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. A DIFFERENT BALLOON WAS USED AS A REMEDIAL ACTION TO FINISH THE CASE. THE PROCEDURE WAS COMPLETED. A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17701948 ↗

Other Catheter, continuous flush devices

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Sources and updates

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