Jade PTA Balloon Dilatation Catheter 597004022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955903991), received between Mar 10, 2026 and Mar 11, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (2 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 18, 2026.

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.

• InjuryMar 11, 2026Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON RUPTURED AND GOT TRAPPED IN-VIVO RESULTING IN SURGICAL CUTDOWN FOR REMOVAL OF THE BALLOON. ADDITIONAL INFORMATION WAS RECEIVED ON 2026/02/13: 1. DID THE BALLOON BECOME FULLY DETACHED OR WAS IT DAMAGED INTACT? - PART OF THE BALLOON BECAME DETACHED AS WELL AS THE BALLOON MARKER. THE OTHER HALF OF THE BALLOON WAS REMOVED FROM THE BODY. 2. WAS THERE ANY BALLOON FRAGMENTS LEFT IN-VIVO OR WAS IT COMPLETELY REMOVED? - IT WAS COMPLETELY REMOVED WITH SURGERY. 3. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) - PROXIMAL SFA, HEAVY CALCIFICATION, ~90-95% STENOSIS. 4. WAS THERE A DELAY IN THE PROCEDURE THAT RESULTED IN PATIENT HARM? IF YES, WHAT WAS THE HARM? - NO. 5. WILL THE FACILITY RELEASE ANY IMAGES OR FILMS OF THE INCIDENT FOR REVIEW BY THE ENGINEERS? - NO. 6. WHAT IS THE STATUS OF THE PATIENT? - STABLE UPON COMPLETION OF THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24573476 ↗
• InjuryMar 10, 2026Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON RUPTURED AND GOT TRAPPED IN-VIVO RESULTING IN SURGICAL CUTDOWN FOR REMOVAL OF THE BALLOON. ADDITIONAL INFORMATION WAS RECEIVED ON 2026/2/13: 1. DID THE BALLOON BECOME FULLY DETACHED OR WAS IT DAMAGED INTACT? PART OF THE BALLOON BECAME DETACHED AS WELL AS THE BALLOON MARKER. THE OTHER HALF OF THE BALLOON WAS REMOVED FROM THE BODY 2. WAS THERE ANY BALLOON FRAGMENTS LEFT IN-VIVO OR WAS IT COMPLETELY REMOVED? IT WAS COMPLETELY REMOVED WITH SURGERY. 3. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) PROXIMAL SFA, HEAVY CALCIFICATION, 90-95% STENOSIS. 4. WAS THERE A DELAY IN THE PROCEDURE THAT RESULTED IN PATIENT HARM? IF YES, WHAT WAS THE HARM? NO 5. WILL THE FACILITY RELEASE ANY IMAGES OR FILMS OF THE INCIDENT FOR REVIEW BY THE ENGINEERS? NO 6. WHAT IS THE STATUS OF THE PATIENT? STABLE UPON COMPLETION OF THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24565781 ↗