Lasso Nav D134909Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835010046), received between Dec 16, 2019 and Dec 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113213); 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.

• MalfunctionDec 16, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A LASSO® 2515 NAV VARIABLE CATHETER, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND RING#11 DAMAGED AND LIFTED. INITIALLY, IT WAS REPORTED THAT THE LASSO CATHETER HAD A KINK IN THE SHAFT AND WAS UNABLE TO ADVANCE THROUGH THE SHEATH. THE KINK WAS OBSERVED CLOSE TO THE DISTAL END. CALLER INDICATED THE CATHETER WAS A CIRCULAR PRE- SHAPED MAPPING CATHETER.RESISTANCE WAS FELT BOTH DURING INSERTION AND REMOVAL OF THE CATHETER. NO EXPOSED WIRES OR SHARP RINGS WERE OBSERVED. CATHETER REPLACEMENT RESOLVED THE ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED KINK AND RESISTANCE WITH THE SHEATH HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 10/1/2019, THE BWI PAL RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL INSPECTION, NO DAMAGE OR ANOMALIES OBSERVED. FURTHER TESTING WAS THEN PERFORMED. DURING A SECOND VISUAL INSPECTION ON 11/18/2019, THE BWI PAL FOUND RING #11 DAMAGED AND LIFTED. HOWEVER, NO KINKS IN THE LOOP CURVATURE WERE FOUND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9474765 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113213. One submission often covers many models, so check the product and lot details in each record.

• Z-1617-2013 · Jun 19, 2013 · Terminated
  20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.