Chameleon CH10-40-75USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521812314), received between Jan 12, 2024 and May 13, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT CAME IN NEEDING A CATHETER EXCHANGE IN THE RIJ (RIGHT INTERNAL JUGULAR VEIN). STENOSIS OF THE VENOTOMY SITE AND THE RIJ TUNNEL WAS SEEN. THE PREVIOUS CATHETER WAS REMOVED, AND A GUIDEWIRE WAS PLACED INTO THE RIJ (RIGHT INTERNAL JUGULAR). A 10X4 PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) BALLOON WAS THEN PLACED OVER THE WIRE AND INTO THE RIJ, WHERE ANGIOPLASTY WAS DONE AT BOTH THE VENOTOMY SITE AND DOWN THE RIJ. AFTER ANGIOPLASTY, THE PTA BALLOON WAS REMOVED, AND A 23-CM (CENTIMETER) COMPETITOR'S HEMODIALYSIS CATHETER WAS ATTEMPTED TO BE INSERTED OVER THE WIRE AND INTO THE PATIENT. THE DIALYSIS CATHETER GOT PAST THE VENOTOMY SITE BUT MET RESISTANCE (STENOSIS) AS IT CONTINUED DOWN RIJ. AT THAT TIME, THE DECISION WAS MADE TO DO MORE ANGIOPLASTY, SO THE DIALYSIS CATHETER WAS REMOVED, AND THE PTA BALLOON WAS PLACED BACK OVER THE WIRE AND DOWN THE RIJ, WHERE ADDITIONAL ANGIOPLASTY OF THE SVA (SUPERFICIAL VENOUS ARTERIALIZATION) AND RIJ WAS PERFORMED USING A 10 MM (MILLIMETER) BALLOON. UPON THE FINAL ANGIOPLASTY, THE BALLOON WAS STILL PARTIALLY INFLATED (THE BALLOON WAS PARTIALLY INFLATED AND PULLED BACK TOWARD THE VENOTOMY SITE INTENTIONALLY BY THE

  Patient problems: Arrhythmia; Discomfort; Foreign Body In Patient; Pain; Unintended Radiation Exposure

  MAUDE report 19305184 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NURSE WENT TO OPEN THE BALLOON AND IT WAS SNAPPED IN HALF. THE BALLOON NEVER TOUCHED THE PATIENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NOTHING ELSE UNUSUAL OBSERVED ON THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO DAMAGE TO THE DEVICE'S PACKAGING AND TO THE DEVICE'S BOX. THE PRODUCT WAS REPLACED WITH DIFFERENT LOT THREE DAYS AFTER THE INCIDENT AND THIS RESOLVED THE ISSUE BUT THEY STILL HAVE SOME OF THESE LOTS NUMBERS ON THEIR SHELF. THERE WERE NO CONFIRMED ISSUES OBSERVED WITH THESE REMAINING LOT NUMBERS ON THEIR SHELF. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 19264486 ↗
• MalfunctionJan 12, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT WAS PRESENTED WITH A NARROWING IN UPPER PORTION OF BRACHIAL VEIN MEDIAL TO A COVERED STENT. THE DOCTOR GAINED INITIAL ACCESS VIA A MICRO PUNCTURE SET, WHERE THE DOCTOR THEN PLACED AN ANGIOCATH FOR INITIAL IMAGING. PROPER FLUSHING PERFORMED OF SHEATH, GUIDEWIRE, AND CATHETER PRIOR TO CASE WITH NORMAL RESULT. ONCE THE LESION WAS IMAGED, A 7FR (FRENCH) COMPETITOR¿S SHEATH WAS INTRODUCED OVER THE WIRE FOLLOWED BY A 10X40 CHAMELEON BALLOON. THE BALLOON WAS ADVANCED TO THE AREA OF STENOSIS AND INFLATED TO RBP (RATED BURST PRESSURE) OF 14. BALLOON WAS THEN RETRACTED TO THE AREA AT THE MEDIAL ENDPOINT OF THE STENT AND ANGIOPLASTY WAS PERFORMED IN A SECOND AREA USING INFLATION DEVICE TO THE RBP. BALLOON WAS DEFLATED AFTER 60 SECONDS, AND IMAGING WAS PERFORMED TO DETERMINE THAT THERE WAS NO RESIDUAL STENOSIS POST ANGIOPLASTY. THE DOCTOR WENT TO REMOVE THE BALLOON AND AS THE DOCTOR PULLED THROUGH THE SHEATH, THE DOCTOR RECEIVED RESISTANCE. THE DOCTOR WAS ABLE TO PULL AGAIN BUT THE RESISTANCE INCREASED AND AT THIS POINT, THE DOCTOR KNEW THAT AT LEAST A PORTION OF THE BALLOON WAS INSIDE THE SHEATH. THE DOCTOR PULLED AGAIN, AND THE BALLOON SEPARATED FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503897 ↗