Occlutech Delivery Set III 98DS008Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885672010249), received between Apr 24, 2024 and Sep 27, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• InjurySep 27, 2024Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  WE HAVE A NEW COMPLAINT REGARDING ODSIII ((B)(4)). THE CUSTOMER (B)(6) STATED IN THE INITIAL EMAIL THAT "ODSIII WAS BROKEN (REF: (B)(4); LOT: DP- 19004)". THE PATIENT WAS TREATED FOR AN EMERGENCY IMPLANTATION OF A VSD (VENTRICULAR SEPTAL DEFECT) OCCLUDER AFTER A HEART ATTACK. THE CUSTOMER STATED THAT DURING THE VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE IMPLANTATION PROCEDURE, DIRECTLY WHEN RELEASING THE DEVICE, THE SHEATH CAME APART DURING IMPLANTATION, WHEN PUSHING THROUGH THE OCCLUDER. NO DAMAGE, THE SHEATH COULD BE REPLACED WITH A NEW ONE. THERE IS A DELAY IN THE PROCEDURE OF MORE THAN 40 MINUTES. THERE WAS A MEDICAL INTERVENTION FOR 11. IMPLANTATION OF AN ASD OCCLUDED. FORTUNATELY, THERE WAS NO HARM TO THE PATIENT, THE ENTIRE SYSTEM (SHEATH AND THE LOADED OCCLUDER) COULD BE PULLED OUT AND REPLACED WITH A NEW SHEATH. THE ISSUE RESOLVED BY UPSIZING THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. SUBMISSION FOR ADMINISTRATIVE PURPOSE AS THERE WAS A DELAY IN THE PROCEDURE OF MORE THAN 40 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322429 ↗
• MalfunctionApr 24, 2024Break; Break

  THE CUSTOMER REPORTED THE SHEATH HAD KINKED. THIS OCCLUTECH DELIVERY SET III (ODSIII) 8F MODEL 98DS008, LOT NUMBER DP-19033 WAS USED IN A VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE PROCEDURE. THE VSD CLOSURE COULD NOT BE FINISHED, AND THE PATIENT MY NEED SURGERY. NO SURGICAL INTERVENTION YET. THE PROCEDURE DELAY WAS NO MORE THAN 30 MINUTES. A SECOND ODSIII WAS USED IN THIS PROCEDURE. DP-19004 IS PROCESSED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176428 ↗
• MalfunctionApr 24, 2024Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  THE CUSTOMER REPORTED THAT THE SHEATH WAS KINKED, AND THE HEMOSTATIC VALVE WAS TORN OFF. THE PROCEDURE COULD NOT BE COMPLETED, THE FIRST ODSIII WAS KINKED AND PULLED THE OCCLUDER THROUGH THE VENTRICLE SEPTUM DEFECT (VSD) AND HAD TO START FROM THE BEGINNING (LOOP AND SO ONE), SECOND ATTEMPT WITH NEW ODS III: THE OCCLUDER WAS IN PERFECT POSITION, DIRECTLY ON VSD, BUT WE COULD NOT PUSH OR PULL THE FLEX PUSHER BECAUSE THE DISTAL PART OF THE FLEX PUSHER WAS DIRECTLY IN FRONT OF THE KINKED PART. WHEN TRYING TO MOVE THE PUSHER, THE HEMOSTATIC VALVE HAS BEEN TORN OFF! WE DECIDED TO FINISH AND NOT TO TRY THE 3RD TIME, BECAUSE OF THE LENGTH OF THE PROCEDURE. THE VSD CLOSURE COULD NOT BE FINISHED, THE PATIENT MAY NEED SURGERY. NO SURGICAL INTERVENTION YET. ADDITIONAL BRAND NAMES USED; OCCLUTECH DELIVERY SET III, 8 F, 98DS008, LOT: DP-19033 AND DP-19004. SEE IMAGES PROVIDED BY THE CUSTOMER. PROCEDURE DELAY WAS NO MORE THAN 30 MINUTES. DP-19033 WILL BE PROCESSED UNDER COMP-24100. DP-19004 WILL BE PROCESSED UNDER COMP-24101.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173476 ↗