Supreme™ 401994Recalls & reported problems
St. Jude Medical Cardiovascular Division · Electrophysiology Catheter · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734201919), received between Jan 22, 2025 and Jan 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETERS WERE NOT VISUALIZED AND NO ELECTROGRAMS WERE APPARENT WHICH CAUSED A DELAY IN PROCEDURE. BOTH CATHETERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21210010 ↗MalfunctionJan 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETERS WERE NOT VISUALIZED AND NO ELECTROGRAMS WERE APPARENT WHICH CAUSED A DELAY IN PROCEDURE. BOTH CATHETERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21210004 ↗
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 · TerminatedSt. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices
- Advisor™ HD Grid, Sensor Enabled™ D-AVHD-DF16St. Jude Medical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 deaths358 reports
- IntellaMap Orion™ M004RC64S0Boston Scientific Corporation · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING6 deaths356 reports
- ACHIEVE™ 990063-020Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING7 deaths129 reports
- Inquiry™ IBI-81104Irvine Biomedical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 recall2 deaths64 reports
- DECANAV R7F282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 deaths108 reports
- LASSO NAV D134301Biosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths82 reports
- DECANAV R7D282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death75 reports
- ACHIEVE ADVANCE™ 2ACH20Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 deaths69 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.