SafeSept Transseptal Guidwire SS-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858769006104), received between May 22, 2026 and May 22, 2026 — classified as 1 death.

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

• DeathMay 22, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A VT PROCEDURE, THE AORTA WAS PERFORATED BY THE NON-ABBOTT WIRE (SAFESEPT) WHICH REQUIRED SURGERY AND THE PATIENT SUBSEQUENTLY DIED. THE PATIENT WAS HIGH RISK AND HAD MULTIPLE MORBIDITIES. DURING TRANSSEPTAL PUNCTURE WITH THE AGILIS SHEATH, BRK NEEDLE, AND A NON-ABBOTT (SAFESEPT WIRE), THE PHYSICIAN PUNCTURED THE AORTA WITH THE SAFESEPT. HE IMMEDIATELY PULLED BACK THE WIRE. HE TRIED AGAIN AND THIS TIME THE PUNCTURE WAS RIGHT, BUT HE COULD NOT PUSH THE AGILIS DILATOR OVER THE HOLE. HE THEN TRIED A 3RD TIME AND WAS ABLE TO DO A SUCCESSFUL TRANSSEPTAL PUNCTURE. AFTER ADVANCING THE ADVISOR HD GRID CATHETER THROUGH THE AGILIS SHEATH IN THE LV HE ASKED THE ATTENDING CO PHYSICIAN TO DO A CARDIAC ULTRASOUND. THEREBY A PERICARDIAL EFFUSION WAS DIAGNOSED. BLOOD PRESSURE DROPPED TO 60/30. A PERICARDIOCENTESIS WAS PERFORMED AND THE REANIMATION TEAM AND CHIEF PHYSICIANS AND HEART SURGERY WERE CONTACTED. THE CHIEF OF EP TOOK OVER AND WAS ABLE TO PULL OUT LARGE AMOUNTS OF BLOOD. BLOOD PRESSURE STABILIZED TO 120/80. THE PHYSICIAN COULD NOT NO LONGER REMOVE ANY MORE BLOOD. PROTAMIN WAS GIVEN, HOWEVER THE PERICARDIUM WAS FILLING AGAIN WITH BLOOD, WHICH CLOTTED AND WAS NOT

  Patient problems: Cardiac Tamponade

  MAUDE report 25255208 ↗