NaviStar NS7TCCL174HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835008555), received between Aug 6, 2020 and Aug 6, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (P990025); 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 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.

• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA/WOLFF-PARKINSON-WHITE SYNDROME (AVRNT/WPW) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING SURGICAL INTERVENTION (PACEMAKER IMPLANTATION). DURING THE CASE, AN AV HEART BLOCK WAS CONFIRMED BY ELECTROCARDIOGRAM (ECG). NO RADIOFREQUENCY WAS BEING DELIVERED AT THE TIME OF THE EVENT; HOWEVER, THE PHYSICIAN HAD ABLATED BEFORE THE EVENT OCCURRED. THE PHYSICIAN IS UNDECIDED ON WHAT THE CAUSE OF THE ADVERSE EVENT WAS, HE BELIEVES IT MAY BE CAUSED EITHER BY THE ABLATION OR BY MANEUVERING THE SHEATH. THE PATIENT¿S CONDITION DID NOT IMPROVE, AND THE PHYSICIAN DECIDED TO IMPLANT A PACEMAKER. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER THE INTERVENTION. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. NO BIOSENSE WEBSTER PRODUCT MALFUNCTIONS NOR ERROR MESSAGES WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10375837 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990025. One submission often covers many models, so check the product and lot details in each record.

• Z-0369-2010 · Oct 2, 2008 · Terminated
  Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02