Occlutech® Steerable Guiding Sheath 51GS012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672009403), received between Oct 27, 2020 and Oct 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2020Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  IT WAS REPORTED THAT DURING THE CLOSURE OF A POSTERO-LATERL MITRAL PARAVALVULAR LEAK PROCEDURE SIDE PORT OF THE FIRST STEERABLE GUIDING SHEATH WAS BROKEN. PHYSICIAN CONTINUED THE PROCEDURE RECONNECTING WITH HIS HANDS THE SIDE PORT TO THE SHEATH. SOON AFTER THAT SHEATH TIP WAS UNABLE TO DEFLECT. PHYSICIAN OPENED SECOND STEERABLE SHEATH BUT AFTER SOME MINUTES INSIDE THE PATIENT SHEATH TIP STOP DEFECTING. PULL WIRE OF THE BOTH SHEATH WAS BROKEN AND STANDING OUT OF THE SHEATH TIP. THERE WAS NO SPECIFIC TECHNIQUE WAS USED FOR INSERTION. PROCEDURE DELAYED FOR 40 MIN AND THERE WAS BLOOD LOSS REPORTED AT THE SIDE PORT DETACHMENT. HOWEVER, THERE WAS NO INTERVENTION REQUIRED TO CONTROL THE BLOOD LOSS. THERE WAS NO PATIENT SIDE EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10743571 ↗