Supreme™ 401860Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734201513), received between Jul 13, 2018 and Oct 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, THE CATHETER BECAME TANGLED AROUND ITSELF WHEN GOING UP THE ILIAC VEIN. IT WAS ATTEMPTED TO UNTANGLE IT BUT SUPPORT FROM AN INTERVENTIONAL SURGEON WAS REQUIRED. WHEN ATTEMPTING TO REMOVE THE CATHETER, IT BROKE AND THE KNOT THAT HAD FORMED WAS STUCK IN THE VEIN. A VASCULAR SURGEON WAS THEN CALLED TO REMOVE THE KNOT THAT REMAINED. THE KNOT WAS REMOVED WITH EASE AFTER THE INITIAL INCISION WAS CUT A LITTLE LARGER THAN BEFORE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23405777 ↗
• InjuryJul 13, 2018Difficult to Remove; Difficult to Remove

  RELATED MANUFACTURING REF: 3005334138-2018-00206. DURING THE PROCEDURE, THE MAPPING AND FIXED CURVE CATHETERS BECAME ENTANGLED AROUND AN INFERIOR VENA CAVA FILTER (IVC) FILTER FROM THE GROIN. THE IVC FILTER WAS SNARED WITH A DEVICE FROM A SUPERIOR IJ ACCESS SITE. ONCE THE IVC FILTER WAS SECURED WITH THE SNARE DEVICE, THE ENTANGLED CATHETERS WERE FREED FROM THE IVC FILTER. THE FILTER WAS THEN COMPLETELY EXTRACTED USING THE SNARE AND A SHEATH FROM THE SUPERIOR ACCESS. THE HANDLE OF THE FIXED CATHETER WAS CUT OFF AS IT WAS STILL ENTANGLED IN THE MAPPING CATHETER AND BOTH DEVICES WERE REMOVED VIA AN INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7684831 ↗

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