Occlutech Delivery Set III 98DS012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885672010355), received between Nov 11, 2023 and Nov 15, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  (B)(6) 2024 DURING DEVICE PREP, FOR CLOSURE OF ATRIAL SEPTAL DEFECT (FASD) IN A PATIENT WITH PULMONARY HYPERTENSION. THE 18MM FENESTRATED ATRIAL SEPTAL DEFECT WAS PULLED BACK IN THE LOADER, AND THE OPERATOR STARTED TO FLUSH TO DE-AIR THE SYSTEM. DESPITE ALL ATTEMPTS, THE LOADER COULD NOT BE DE-AIRED DUE TO AIR ENTERING THE LOADER THROUGH THE PROXIMAL HEMOSTATIC VALVE, WHERE THE PUSHER IS INSERTED. ADDITIONAL ATTEMPTS WERE MADE TO KEEP THE PUSHER STRAIGHT WITH THE LOADER AND THE SALINE BOWL TILTED WITH THE DISTAL END OF THE LOADER SUBMERGED, AS WELL AS HOLDING THE LOADER UPRIGHT WITH THE PUSHER AND LOADER STRAIGHT. THE AIR WAS STILL ENTERING THE LOADER THROUGH THE PROXIMAL HEMOSTATIC VALVE. THE 12F ODSIII SYSTEM WAS ABANDONED, AND AN ODS 12F SYSTEM WAS USED INSTEAD. NO ISSUES OCCURRED WITH THE ODSI SHEATH. THE ISSUE WAS RESOLVED WHEN THE OLDER MODEL ODS L WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE ARE NO PICTURES, OR IMAGES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694484 ↗
• MalfunctionJun 28, 2024Air/Gas in Device; Air/Gas in Device

  INITIALLY, THE DOCTOR USED NORMAL SALINE TO FLUSH THE LOADER AND REMOVE THE AIR INSIDE THE TUBE OF THE LOADER. 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. PRODUCT WILL BE RETURNED. 06/20/2024 FOLLOW UP INFORMATION RECEIVED: THE DOCTOR FEELS THAT WHEN THE PUSHER INSERTS INTO THE LOADER, THE AIR BUBBLE EASILY GOES INTO THE LOADER. THE AIR-BUBBLE GOES INTO THE LOADER DURING THE PREPARATION ON STERILE TABLE. THE PATIENT WAS NOT INVOLVED AT THE TIME THE BUBBLES WERE FOUND. ONLY DURING THE PREPARATION PROCEDURE. NO DELAY IN THE PROCEDURE, WITHIN 30 MINUTES. DOCTOR USED PRESSURE BAG TO CONTINUOUSLY FLUSH NORMAL SALINE INTO LOADER TO PREVENT THE BUBBLE INTO THE LOADER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634371 ↗
• MalfunctionJan 30, 2024Air/Gas in Device; Air/Gas in Device

  DURING IMPLANT PROCEDURE OF AN ATRIAL SEPTUM DEFECT (ASD) CLOSURE, THE ODS III DELIVERY SYSTEM (12 FRENCH) WAS PREPARED VERY WELL AND VERY PROFESSIONALLY. THE PHYSICIAN IS TRAINED TO THE DELIVERY SYSTEM III VERY GOOD, AND HE ALSO HAS USED IT A LOT WITHOUT ANY PROBLEMS. IN THIS CASE HE HAS FLUSHED THE SYSTEM SEVERAL TIMES, BUT HE COULD NOT GET THE LOADER AIR-FREE. WHILE USING THE ODS III, A FIGULLA FLEX II ASD OCCLUDER REF29ASD27, SERIAL NUMBER (B)(6) WAS INSERTED THROUGH THE SHEATH/LOADER AT THE TIME OF THE EVENT. THE PHYSICIAN DECIDED TO SWITCH TO THE ODS I DELIVERY SYSTEM 12F. WHEN USING THE ODS I DELIVERY SYSTEM 12F THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, HOWEVER THERE WAS A 3- OR 4-MINUTE DELAY, WHEN CHANGING OUT THE ODS III FOR THE ODS I DEVICE. AFTER THE PROCEDURE THE PATIENT ALSO FELT GOOD WITHOUT ANY RESTRICTION AND LEFT THE CATH LAB WITHOUT ANY COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606381 ↗
• MalfunctionDec 5, 2023Air/Gas in Device; Air/Gas in Device

  DURING AN ASD PROCEDURE, THERE WAS A PROBLEM, AIR GOT INSIDE THE HEMOSTAIC VALVE; IT TOOK ON AIR DURING PREPARATION OF THE DELIVERY SET. THE DELIVERY SET WAS REPLACED WITH ANOTHER DELIVERY SET, SAME MODEL AND SAME LOT NUMBER. THE OCCLUDE WAS INSERTED THROUGH THE SHEATH DURING THE PROCEDURE AND THE IMPLANTATION WAS SUCCESSFUL. THERE WAS NO PROCEDURE DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268027 ↗
• MalfunctionNov 11, 2023Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED PRIOR TO PATIENT CONTACT, DURING DEVICE PREPARATION BUT BEFORE DEVICE POSITIONING OF AN ODS III. WHILE FLUSHING THE LOADER WITH THE DEVICE INSIDE, THERE WAS AIR ENTERING FROM THE HAEMOSTATIC VALVE. IT COULD BE REMOVED, BUT AFTER THAT, THE PHYSICIAN DIDN'T TRUST THE VALVE ANYMORE AND WANTED TO USE AN ODS I. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. THERE WERE NO REPORTED ADVERSE SIDE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117046 ↗