inforMED
MalfunctionNLH

NA

Received May 12, 2026 · Event occurred Feb 9, 2026

Report 0002090040-2026-00012 · MDR key 25154700

Device

Generic name

Catheter, Recording, Electrode, Reprocessed

Model number

81104

Catalog number

81104

Lot number

5602490SH

Product problems

  • Mechanical Problem
  • Use of Device Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

IT WAS REPORTED CATHETER PRODUCED S CURVE INSTEAD OF A U CURVE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.