N/A (REF D134301)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825011680), received between Jan 9, 2025 and Mar 10, 2025 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

4 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.

Recalls naming this device

1. May 10, 2024Open, Classified

   Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

   Z-2268-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO BEND, SO WE REPLACED THE ORIGINAL WITH A REPLACEMENT. 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 21566956 ↗
• MalfunctionJan 9, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE TIP DOES NOT BEND AND DEFLECTION STOPS MIDWAY. 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 21115078 ↗

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-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-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
• 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