Venos Occlusion Balloon Catheter V068010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836559006923), received between Feb 19, 2018 and Apr 3, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Air Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2018Air Leak; Air Leak

  THE CUSTOMER REPORTED WHILE THE BALLOON WAS IN THE TARGET VEIN, IT DOES NOT ASPIRATE BLOOD. BUT AIR CAME INTO THE SYSTEM. DID THE EVENT OCCUR DURING SURGERY? - YES. WAS THE PATIENT SUBJECTED TO PROCEDURES WHICH MIGHT HAVE DAMAGED THE DEVICE? NO. DID THE EVENT CAUSE AN ADVERSE CHANGE IN THE PATIENT'S CONDITION? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7393243 ↗
• InjuryFeb 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED DISSECTION OF CORONARY SINUS, SLIGHT PERICARDIAL EFFUSION. DURING LAO 30 DEGREE ANGULATION WITH BALLOON DIRECTED CORONARY SINUS ANGIOGRAPHY DISSECTION OF THE CORONARY SINUS WITH VISIBLE SLIGHT PERICARDIAL EFFUSION. WITHDRAWAL OF THE HOOK SHEETH. THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEAD WERE LEFT IN PLACE, THE DEVICE IMPLANTED AND CONNECTED TO THE CRT-DEVICE. PROGRAMMING AAI 30 0,2V/0,1MS. TTE VERIFICATION OF NON-SIGNIFICANT PERICARDIAL EFFUSION. THE PATIENT WAS TRANSFERRED HEMODYNAMICALLY STABLE TO THE INTENSIVE CARE UNIT FOR MONITORING. RE-DO PROCEDURE WITH LEFT VENTRICULAR LEAD PLACEMENT IS PLANNED IN 4 WEEKS. WE WANTED TO REPRESENT THE CS FROM TWO LEVELS. AT THE FIRST PRESENTATION WITH BALLOON IN THE CATHETER IN THE AP, THERE WAS NO VISIBLE PERFORATION OF THE CS. TO GET A BETTER OVERVIEW, WE WANTED A SECOND JUST VIEW. WE THEN SET LAO TO 30 DEGREE. AND IN THIS PRESENTATION OF THE CS SAW A PERFORATION OF THE CS. HAS A POSSIBLE DEFICIENCY WITH THE DEVICE BEEN OBSERVED? NO. DID THE EVENT OCCUR DURING SURGERY? YES. DID THE EVENT CAUSE AN ADVERSE CHANGE IN THE PATIENT'S CONDITION? YES DISSECTION OF CORONARY SINUS, SLIGHT PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 7281227 ↗