Chameleon 6x40Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290016745023), received between Oct 26, 2021 and Nov 18, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE 6MM X40MM PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) BALLOON WAS INFLATED TO ITS R ATED BURST PRESSURE (25ATM) AND A PROLONGED ANGIOPLASTY WAS BEING PERFORMED. THE INTENDED TIME TO HOLD THE BALLOON WAS 3 MINUTES. AT THE 2 MINUTE AND 30 SECOND MARK THE BALLOON POPPED AND LOST ALL INFLATION. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED AND NO CLEANING AGENTS WAS USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS TREATED WITH PRIOR TO PRODUCT PLACEMENT. THERE WAS A LEAK, AND IT WAS LOCATED WHERE THE BALLOON POPPED LINEAR DOWN THE SHAFT OF THE CATHETER. THE BALLOON WAS SUCCESSFULLY REMOVED WITH NO HARM TO THE PATIENT. ALTHOUGH THE BALLOON POPPED BEFORE THE INTENDED HOLD TIME THE ANGIOPLASTY WAS CONFIRMED SUCCESSFUL AFTER REMOVING THE BALLOON AND SHOOTING CONTRAST THROUGH THE SHEATH AND THE DEVICE WAS REPLACED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND INSUFFLATOR/GUIDEWIRE WAS UTILIZED WITH THE DEVICE. FLUSHING DONE PER IFU(INSTRUCTION FOR USE). THERE WAS NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO EXCESSIVE FORCE USED TO PULL/TAKE OUT THE PRODUCT AND THE EVENT DID N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825730 ↗
• InjuryMar 1, 2022Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PHYSICIAN OBSERVED AND REPORTED THAT THE BALLOON WAS DIFFICULT TO DEFLATE (JUST AN OBSERVATION NOT A QUALITY ISSUE). IT WAS STATED THAT WHEN THE BALLOON WAS BEING REMOVED FROM THE PATIENT, THE BALLOON WAS CAUGHT IN THE INTRODUCER SHEATH (6 FRENCH GAUGE (FR), CORDIS) AND AS RESULT THE BALLOON SEPARATED FROM THE CATHETER AND WAS BROKEN INTO TWO PIECES (THE BROKE IN TWO PIECES REFER TO THE CATHETER AS ONE PIECE AND THE BALLOON AS THE SECOND PIECE. THE BALLOON REMAINED INTACT). THE BALLOON WAS RETRIEVED WITHOUT SURGICAL INTERVENTION BECAUSE IT BROKE WITHIN THE SHEATH INSTEAD OF THE VESSEL. IT WAS STATED THAT TO RESOLVE THE ISSUE THE BALLOON WAS REMOVED TOGETHER WITH THE INTRODUCER SHEATH AND THE PROCEDURE WAS COMPLETED. X-RAY/ FLUORO WAS REQUIRED TO CHECK IF ALL PIECES WERE ACCOUNTED FOR AND THE BALLOON WAS ALSO EXAMINED TO ENSURE IT WAS INTACT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PER INSTRUCTION FOR USE (IFU) AND THERE WAS NO UNEXPECTED RESULT, NO OTHER PRODUCTS WERE UT

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13642705 ↗
• MalfunctionFeb 16, 2022Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, THEY APPROACHED THE PATIENT WITH RETROGRADE APPROACH, AND USED IT IN A CASE WITH SIGNIFICANT STENOSIS IN THE ANASTOMOTIC PART. WHILE RECEIVING RESISTANCE DUE TO STENOSIS TO THE ARTERY SIDE BEYOND THE ANASTOMOTIC SITE, THE TIP OF THE PRODUCT WAS ADVANCED, AND THE STENOSIS STATUS WAS CONFIRMED WITH CONTRAST AGENT. AFTERWARDS, WHEN THE PATIENT FELT RESISTANCE AND TRIED TO PULL THE PRODUCT TO INFLATE THE BALLOON, THE BACK END OF THE BALLOON BROKE AND IT DID NOT INFLATE. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542273 ↗
• MalfunctionNov 3, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, DURING BALLOON INFLATION, IT WAS STATED THAT THE BALLOON BURST, RUPTURED AND LEAKED ON OUTFLOW LESION PROCEDURE. 20-25 ATMS INFLATION PRESSURE AND APPROXIMATELY 4-5 INFLATIONS WERE APPLIED TO THE BALLOON PRIOR TO THE RUPTURE/BURST OR LEAK. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S BALLOON. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12748263 ↗
• MalfunctionOct 26, 2021Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE REPORTER, DURING BALLOON INFLATION, IT WAS STATED THAT THE BALLOON BURST, RUPTURED, LEAKED ON OUTFLOW LESION PROCEDURE. 20-25 ATMS INFLATION PRESSURE AND APPROXIMATELY 4-5 INFLATIONS WERE APPLIED TO THE BALLOON PRIOR TO THE RUPTURE/BURST OR LEAK. IT WAS STATED THAT THE LEAK WAS DUE TO THE RUPTURED BALLOON. THE PROCEDURE WAS COMPLETED AND SUCCESSFULLY USED WITH A COMPETITORS BALLOON. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12697660 ↗