Occlutech Delivery Set III 98DS010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885672010300), received between Aug 2, 2023 and Mar 17, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2025Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  PRIOR TO IMPLANTATION OCCLUDER WAS FLUSHED, LOADED 2X AND ALWAYS FLUSHED WITH WATER TO REMOVE AIR BUBBLES FROM THE DEVICE AND MATERIAL. SHEATH WAS FLUSHED AS WELL AND ONCE PLACED IN THE PATIENT WE ASPIRATED 20ML OF BLOOD TO REMOVE AIR FROM THE SHEATH AFTER DILATOR REMOVAL. THEN LOADER TOGETHER WITH THE OCCLUDER WAS UNDER CONSTANT FLUSH CONNECTED TO THE DELIVERY SHEATH. AFTER THE LEFT SIDE OF THE OCCLUDER WAS DEPLOYED ECG HAS CHANGED AND THE PATIENT FELT CHEST PAIN AND SHORTNESS OF BREATH. AIR EMBOLIE WAS SUSPECTED. AFTER 5-7 MIN ECG WAS AGAIN NORMAL AND THE CHEST PAIN WAS LESS PRESENT IN THE PATIENT. THE DEVICE WAS IMPLANTED, AND THE PATIENT WAS DISCHARGED WITHOUT ANY CONSEQUENCES. DEVICE WAS DISCARDED BY HOSPITAL. CONSEQUENCES TO EVENT: AIR ENTERING INTO VASCULAR SYSTEM & EMBOLISM. (B)(6)2025: CUSTOMER PROVIDED ADDITIONAL DETAILS: PROCEDURE TAKING PLACE WHEN ISSUE WAS FOUND WAS TO CLOSE THE PFO (PATENTED FORAMEN OVALE). IT IS UNKNOWN EXACTLY WHEN THE AIR GOT INTO THE DEVICE BUT IT WAS NOTICED (ECG CHANGED AND PATIENT COMPLAINED ABOUT THE CHEST PAIN AND BREATHING ISSUES) SHORTLY AFTER THE LEFT SIDE OF THE PFO DEVICE WAS DEPLOYED. THERE WAS A SHORT DELAY OF 10-15 MORE MINUTES UNTIL

  Patient problems: Air Embolism

  MAUDE report 21621822 ↗
• MalfunctionJun 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PREPARATION, THE LOADER WAS IN THE WATER, OUR FLEX PUSHER WAS IN THE LOADER AND THE USER JUST WANTED TO CONNECT THE PUSHER WITH THE BALL CONNECTOR ON THE OCCLUDER. IN THIS MOMENT I SAW THERE IS SOMETHING WRONG, THE USER PUT IT OUT OF WATER AND THE PINK HALF RING WAS NOT ON ITS PLACE. ANOTHER DEVICE USED TO COMPLETE PROCEDURE. NO PATIENT INVOLVEMENT REPORTED, NO ADDITIONAL INFORMATION AVAILABLE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632519 ↗
• MalfunctionAug 2, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  DURING AN ASD IMPLANT PROCEDURE, WHEN FLUSHING LOADED ASD DEVICE WITHIN THE LOADER PRIOR TO PLACEMENT INTO DELIVERY SHEATH, AIR BUBBLES COULD BE SEEN ENTERING THE LOADER CHAMBER VIA THE HEMOSTATIC VALVE AT THE PROXIMAL END THROUGH WHICH THE PUSHER WAS PASSED. PLACING A THUMB OVER THE DISTAL END OF THE LOADER AND FLUSHING RESULTED IN LIQUID SQUIRTING THROUGH HEMOSTATIC VALVE AT LOW PRESSURE, LOADER VALVE INTEGRITY. ALL BUBBLES WERE SUCCESSFULLY FLUSHED, AND CASE WENT AHEAD SUCCESSFULLY. LOADER IS AVAILABLE FOR RETURN AND ANALYSIS. CASE ENDED IN SUCCESSFUL POSITIONING OF ASD DEVICE. CUSTOMER COMPLAINT ONLY RELATES TO VALVE ON LOADER, REMAINDER OF ODSIII KIT FUNCTIONED APPROPRIATELY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443094 ↗