N/A (REF D134302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825011697), received between Mar 18, 2026 and Mar 18, 2026 — classified as 1 malfunction.

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

5 other recalls cover devices cleared under the same FDA submission (K112292); 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.

• MalfunctionMar 18, 2026Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THE CATHETER DOES NOT BEND. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634382 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112292. One submission often covers many models, so check the product and lot details in each record.

• Z-2268-2024 · May 10, 2024 · Open, Classified
  Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
• Z-0766-2019 · Dec 17, 2018 · Terminated
  BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical
• Z-0467-2019 · Aug 23, 2018 · Terminated
  Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
• Z-0917-2018 · Jan 2, 2018 · Terminated
  Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysi
• Z-0916-2018 · Jan 2, 2018 · Terminated
  Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysi