Occlutech Delivery Set III 98DS014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885672010362), received between Oct 23, 2023 and Sep 21, 2026 — classified as 3 malfunctions.

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

• MalfunctionSep 21, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843910 ↗
• MalfunctionJul 15, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  DURING AN IMPLANTATION PROCEDURE, THE PHYSICIAN WANTED TO INSERT THE ODSIII SHEATH 14F INTO THE FEMORAL VEIN AND DISCOVERED THAT THE CONNECTION BETWEEN THE VALVE AND THE SHEATH WAS NOT TIGHT. THE PHYSICIAN WAS ABLE TO PULL THE VALVE OFF THE SHEATH EASILY. IT WAS THEN SWITCHED TO A NEW ODSIII SHEATH 14F AND THE IMPLANTATION WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER INCIDENTS. THE PATIENT LEFT THE CATH LAB WITHOUT ANY COMPLAINTS AND WAS IN GOOD CONDITION. IT WAS ALSO REPORTED THE VALVE WAS NOT FIRMLY CONNECTED TO THE SHEATH. THERE WAS NO GAP AT VALVE WHEN THE DILATOR WAS INSERTED OR ANY OTHER ANCILLARY DEVICE. THE VALVE HAS DETACHED ITSELF FROM THE SHEATH. NO PICTURES OR VIDEO AVAILABLE AND NO DELAY IN THE PROCEDURE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. NO ANATOMICAL ABNORMALITIES PATIENT WAS A YOUNG SLIM MAN. DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510237 ↗
• MalfunctionOct 23, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THE EVENT OCCURRED DURING PATIENT CONTACT. THE COMPLAINT AFFECTS THE LOADER, WHILE FLUSHING WITH THE DEVICE IN IT, THERE WERE AIR BUBBLES ENTERING THE LOADER FROM THE HEMOSTATIC VALVE. AFTER FLUSHING THE DEVICE, AIR GOT IN THE LOADER AGAIN WHILE BRINGING THE LOADER TO THE SHEATH. AS SOON AS THE PUSHER SLIGHTLY MOVED, THERE WAS AIR ENTERING THE LOADER AGAIN FROM THE HEMOSTATIC VALVE. THE PHYSICIAN HOLDS THE PUSHER AND LOADER COMPLETELY STILL SO THAT IT WORKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985188 ↗