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Stryker Sustainability Solutions recalls Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 40194
Recalled November 16, 2016 · FDA recall Z-0380-2017 · Stryker Sustainability Solutions
Hazard
The EP Catheters may be mislabeled for French size during reprocessing. · FDA Class II
Units
4 devices
Sold at
U.S. distribution to the following; AZ, MN and MO.
Description
The EP Catheters may be mislabeled for French size during reprocessing.
Product
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Manufacturer(s)
Stryker Sustainability Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →