CHOCOLATE IPN914595Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156105464), received between Sep 13, 2022 and Sep 13, 2022 — classified as 1 death.

The most frequently reported specific device problem is “Entrapment of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• DeathSep 13, 2022Entrapment of Device; Entrapment of Device

  AS REPORTED: THE CHOCOLATE XD BALLOON WAS INFLATED IN THE OM BRANCH OF THE CIRCUMFLEX ARTERY TO DILATE A CALCIFIED IN-STENT RESTENOSIS. THE BALLOON WAS DEFLATED AND UPON REMOVAL, THE CAGE WAS LODGED IN THE VESSEL. WHEN IT WAS PULLED BACK THE BALLOON AND NITINOL CAGE WERE SEPARATED FROM THE SHAFT. EVERY INTERVENTIONAL ATTEMPT WAS MADE TO REMOVE THE DEVICE (SNARES, ASPIRATION, GUIDE EXTENSION). THE DEVICE WAS UNABLE TO BE RETRIEVED FROM THE VESSEL. THE PATIENT BECAME UNSTABLE AND REQUIRED ECMO SUPPORT. ADDITIONAL INFORMATION ON 06 SEPT 2022: THE PATIENT IS STILL ON ECMO, INTUBATED AND IN THE ICU. PATIENT'S CURRENT CONDITION IS REPORTED AS SERIOUS. THE PATIENT RECEIVED CPR AND WAS INTUBATED AND VENTILATED DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15411155 ↗