Chameleon CH06-40-75USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521812277), received between Jun 30, 2023 and Jul 27, 2023 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2023Fracture; Leak/Splash; Fracture; Leak/Splash

  ACCORDING TO THE REPORTER, WHEN THE CONTRAST MEDIUM WAS INJECTED THROUGH THE INJECTION PORT, THE CONTRAST MEDIUM LEAKED FROM A PORTION OTHER THAN THE DRAINAGE HOLE. THERE WAS A LEAK AT THE CATHETER SHAFT. THERE WAS NO LUER ADAPTER PROBLEM. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. TEGO WAS NOT UTILIZED, AND THE INSERTION SITE WAS NOT HANDLED PRIOR TO PRODUCT PLACEMENT. INTERVENTION/TREATMENT WAS NOT REQUIRED AS A RESULT OF THE EVENT. AS A REMEDIAL ACTION THE CATHETER WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS RELATED TO THIS EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. MOZARC PERFORMED AN EVALUATION OF THE REPORTED CATHETER AND THE INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT VISUAL INSPECTION OF THE DEVICE NOTED THAT THERE WAS A CRACK ON THE LUER PORT FOR THE CONTRAST MEDIA. THE CRACK LEAKED WHEN THE PORT WAS FLUSHED WITH WATER. THE PACKAGING WAS NOT RETURNED, SO THE ROOT CAUSE OF THE OBSERVED DAMAGE COULD NOT BE RELIABLY DETERMINED, HOWEVER ALL DEVICES ARE TESTED FOR LE AKS BEFORE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402805 ↗
• MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel

  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 BEFORE THE RATED BURST PRESSURE WAS REACHED, HAD TORN AND WAS TEARING AT THE CONNECTION SITE NEXT TO WHERE THE SILVER PORT OPENING WAS (ON THE FRONT END OF THE BALLOON) BUT THE BALLOON DID NOT COMPLETELY SEPARATE FROM THE SHAFT AND NO PORTION OF DEVICE FELL IN PATIENT. THE CONNECTION ISSUE WAS AT THE SILVER PORT AND BALLOON. THE BACK END ¿HUB¿ WAS FINE. 7 FR COMPETITOR'S INTRODUCER SHEATH WAS USED. THE SIZE OF GUIDEWIRE WAS .035. THERE WAS NO ISSUE WITH THE HUB OR LUER. 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 TR

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

  MAUDE report 17237639 ↗