Jade PTA Balloon Dilatation Catheter 596008022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955903908), received between Sep 18, 2024 and Sep 25, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• InjurySep 25, 2024Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  A 6MM, 80% STENOSED, HEAVILY CALCIFIED POPLITEAL ARTERY (PA) WAS THE TARGET TREATMENT AREA. THE JADE BALLOON WAS ADVANCED WITH THE AID OF A COMMAND ES GUIDE WIRE. THE JADE BALLOON WAS INFLATED MULTIPLE TIMES TO 28 ATMOSPHERE PRESSURE (ATM), PAST THE BURST PRESSURE, RESULTING IN A BALLOON RUPTURE. WHEN ATTEMPTING TO REMOVE THE JADE BALLOON, IT COULD NOT BE REMOVED. A SNARE WAS USED BUT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR SURGERY AND HAD THE JADE BALLOON REMOVED. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION RECEIVED ON 9/06/2024, THE PATIENT IS STILL HOSPITALIZED. THE PHYSICIAN STATED, THE JADE BALLOON WASN'T INTENTIONALLY INFLATED TO BURST BUT WAS INFLATED PAST BURST PRESSURE DUE TO A VERY RESISTANT LESION. WHEN THE JADE BALLOON RUPTURED, NO DETACHMENT WAS OBSERVED. THE COLLAPSED JADE BALLOON COULD NOT BE SUCCESSFULLY REMOVED WITHOUT SURGERY INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20301639 ↗
• InjurySep 18, 2024Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  A 6MM, 80% STENOSED, HEAVILY CALCIFIED POPLITEAL ARTERY (PA) WAS THE TARGET TREATMENT AREA. THE JADE BALLOON WAS ADVANCED WITH THE AID OF A COMMAND ES GUIDE WIRE. THE JADE BALLOON WAS INFLATED MULTIPLE TIMES TO 28 ATMOSPHERE PRESSURE (ATM), WHEN ATTEMPTING TO REMOVE THE JADE BALLOON, IT COULD NOT BE REMOVED. A SNARE WAS USED BUT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR SURGERY AND HAD THE JADE BALLOON REMOVED. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, THE PATIENT IS STILL HOSPITALIZED. THE PHYSICIAN STATED, THE JADE BALLOON WASN'T INTENTIONALLY INFLATED TO BURST BUT WAS INFLATED PAST BURST PRESSURE DUE TO A VERY RESISTANT LESION. WHEN THE JADE BALLOON RUPTURED, NO DETACHMENT WAS OBSERVED. THE COLLAPSED JADE BALLOON COULD NOT BE SUCCESSFULLY REMOVED WITHOUT SURGERY INTERVENTION. BACKGROUND: PATIENT INFORMATION: 44 YEARS, MALE, 110 KG. ADDITIONAL INFORMATION WAS RECEIVED ON 2024/9/14 AS BELOW: 1. THE VESSEL WAS 6MM, 80% STENOSED, HEAVILY CALCIFIED POPLITEAL ARTERY (PA) 2. TO CLARIFY, WAS THE BALLOON INTENTIONALLY BURST? NOT INTENTIONALLY , VERY RESISTANT LESION 3. HOW MANY TIMES WAS THE BALLOON INFLATED? IF MULTIPLE TIMES, AT WHA

  Patient problems: Foreign Body In Patient

  MAUDE report 20243840 ↗