Sterile Interface Cable D133701Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835010121), received between May 29, 2026 and May 29, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (P240006); 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.

• MalfunctionMay 29, 2026Communication or Transmission Problem; Electrical Shorting

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A STERILE INTERFACE CABLE AND A SIGNAL INTERFERENCE (NOISE/LOSS) ISSUE OBSERVED ON THE IC, BS, OR ALL ECG (BS + IC) CHANNELS ON ALL SYSTEMS AND THE EKG BECAME UNAVAILABLE FOR THE PHYSICIAN TO MONITOR THE PATIENT¿S HEART RHYTHM. INITIALLY IT WAS REPORTED THAT THERE WAS A "CURRENT LEAK" ALERT BEING DISPLAYED ON THE TRUPULSE¿ MONITOR. THEY REPLACED THE VARIPULSE¿ CATHETER CABLE (STERILE INTERFACE CABLE) AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-MAY-2026. A SIGNAL INTERFERENCE (NOISE/LOSS) ISSUE WAS OBSERVED ON THE INTRACARDIAC (IC), BODY SURFACE (BS), OR ALL ECG (BS + IC) CHANNELS ON ALL SYSTEMS. THE EKG BECAME UNAVAILABLE FOR THE PHYSICIAN TO MONITOR THE PATIENT¿S HEART RHYTHM. THE CATHETER WAS IN THE PATIENT¿S BODY. THE "CURRENT LEAK" ALERT EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 20-MAY-2026 OF A SIGNAL INTERFERENCE (NOISE/LOSS) ISSUE OBSERVED ON THE IC, BS, OR ALL ECG (BS + IC) CHANNELS ON ALL SYSTEMS AND THE EKG BECAME UNAVAILABLE FOR THE PHYSICIAN TO MONITOR THE PATIENT¿S HEART RHYTHM AND HAVE ASSESSED THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337203 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P240006. One submission often covers many models, so check the product and lot details in each record.

• Z-1205-2025 · Jan 5, 2025 · Completed
  VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recordin