Supreme™ 401890Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734201667), received between Aug 13, 2019 and Aug 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

1 other recall cover devices cleared under the same FDA submission (K894500); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 13, 2019Difficult to Remove; Difficult to Remove

  DURING AN ELECTROPHYSIOLOGY (EP) PROCEDURE DEVICE ENTANGLEMENT OCCURRED. AT THE START OF THE CASE THE SUPREME EP CATHETER WAS INTRODUCED INTO THE PATIENT THROUGH THE RIGHT FEMORAL VEIN. THE EP CATHETER WAS THEN MOVED TO THE LEFT FEMORAL VEIN IN ORDER TO INTRODUCE THE ABLATION CATHETER. THE EP CATHETER WAS INSERTED INTO THE 5FR SHEATH IN THE LEFT FEMORAL VEIN BUT WOULD NOT REACH THE HEART. UNDER FLUOROSCOPY THE CATHETER APPEARED TO HAVE LOOPED INTO A KNOT. FOLLOWING UNSUCCESSFUL ATTEMPTS TO UNDO THE KNOT THE PROCEDURE WAS CONTINUED WITH THE EP CATHETER IN THE LEFT FEMORAL VEIN AND A NEW EP CATHETER WAS PLACED VIA A SEPARATE LEFT SIDED VENOUS ACCESS. WHEN THE PROCEDURE WAS COMPLETED THE USER ATTEMPTED TO REMOVE THE KNOT AGAIN BUT WHEN IT STILL COULD NOT BE UNDONE THE ENTIRE SYSTEM OF THE SHEATH AND CATHETER WERE REMOVED AS A SINGLE UNIT. THE REMOVAL OF THE SHEATH AND CATHETER HAD NO ADVERSE IMPACT ON THE PATIENT. A ROUTINE SUTURE STITCH WAS USED TO CLOSE THE ACCESS SITE AND MANUAL PRESSURE WAS APPLIED FOR 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K894500. One submission often covers many models, so check the product and lot details in each record.

• Z-0177-2015 · Oct 14, 2014 · Terminated
  St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353