Occlutech Delivery Set III 98DS011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885672010331), received between Jul 12, 2024 and Jul 28, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057436 ↗
• InjuryDec 18, 2025Break; Air/Gas in Device; Break; Air/Gas in Device

  DURING THE ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE, THE ASD SIZE WAS MEASURED BY TEE, AND AN ASD OCCLUDER DEVICE SIZE 24 MM AND OCCLUTECH DELIVERY SET III 11F WERE SELECTED. THE EQUIPMENT PREPARED BY THE NURSE WHILE FLUSH SHOWED NO ABNORMALITIES. HOWEVER, WHILE THE PHYSICIAN WAS ABOUT TO DEPLOY THE ASD OCCLUDER DEVICE, THE LOADER DEVICE BROKE INTO TWO SEPARATE PARTS. THIS RESULTED IN AIR ENTERING THROUGH THE FRACTURED PROXIMAL END OF THE LOADER DEVICE INTO THE PATIENT'S CIRCULATION, CAUSING BRADYCARDIA. IMMEDIATELY AFTER THE INCIDENT, THE PHYSICIAN ORDERED A RAPID INFUSION OF 200 ML NSS TO CORRECT THE PATIENT'S ARRHYTHMIA AND PROMPTLY REPLACED BOTH THE DELIVERY SET AND THE LOADER DEVICE. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 10-15 MINUTES, INCLUDING THE TIME REQUIRED TO OPEN A NEW DEVICE AND TO LOAD NSS TO MANAGE THE BRADYCARDIA. THE PROCEDURE WAS THEN CONTINUED AND SUCCESSFULLY COMPLETED. THE PATIENT IS CURRENTLY IN GOOD CONDITION AND HAS NO ONGOING ISSUES. THE DEVICE WILL BE RETURNED.

  Patient problems: Air Embolism; Arrhythmia; Bradycardia

  MAUDE report 23846455 ↗
• MalfunctionJul 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  INITIALLY, THE DOCTOR USED NORMAL SALINE TO FLUSH THE LOADER AND REMOVE THE AIR INSIDE THE TUBE OF THE LOADER. DURING INCOMING INSPECTION AFTER THE DOCTOR LOADED THE ASD INSIDE THE LOADER, THE DOCTOR FOUND AIR BUBBLES CONTINUOUSLY GOING INTO THE TUBE OF THE LOADER. DOCTOR CONTINUOUSLY FLUSHED THE LOADER A FEW TIMES, BUT AIR BUBBLES STILL GOT INTO THE TUBE FROM THE HEMOSTATIC VALVE. THEY OPENED A NEW DELIVERY SYSTEM 12F TO SEE ANY IMPROVEMENT. BUBBLES STILL CAME INTO THE LOADER FROM THE HEMOSTATIC VALVE. THE DOCTOR FINALLY USED A PRESSURE BAG TO CONTINUOUSLY FLUSH NS WATER INTO THE LOADER TO PREVENT AIR BUBBLES GOING INTO THE LOADER TUBE AGAIN AND FINALLY FINISHED THE PROCEDURE. 27/JUN/2024: ADDITIONAL INFORMATION. THIS 98DS011 WAS USED IN AN ATRIAL SEPTAL DEFECT (ASD) PROCEDURE. THERE WAS NO PATIENT DIRECTLY INVOLVED, AS THE EVENT OCCURRED WHEN THE DOCTOR WAS DOING THE DE-AIR PROCEDURE ON THE STERILE TABLE. THE DOCTOR DIDN'T CONFIRM EXACTLY WHAT THE COMPATIBILITY PROBLEM WAS, HOWEVER, THE DOCTOR FEELS THAT THE AIR SHOULD GO EASY INTO THE LOADER AFTER THE PUSHER IS INSERTED INTO THE VALVE. NO DELAY IN PROCEDURE, WAS WITHIN 30 MINUTES. THE ISSUE WAS RESOLVED WHEN THE DOCTOR USED PRES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731155 ↗