Z-0380-2017Class II

Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers...

Name: Z-0380-2017 Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers...
Creator: Stryker Sustainability Solutions
Published: 2016-10-06
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2016-10-06 / Terminated / root cause: labeling and UDI

FDA source

Stryker Sustainability Solutions began a recall of Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409... on 2016-10-06. FDA classified it as Class II and gives the reason as "The EP Catheters may be mislabeled for French size during reprocessing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0380-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-06
Posted: 2016-11-09
Terminated: 2016-12-16
Recalling firm: Stryker Sustainability Solutions
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.
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: The EP Catheters may be mislabeled for French size during reprocessing.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/6/2016 to its customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the recalled product. Other EP Catheters reprocessed by Stryker Sustainability Solutions should be considered as alternatives. To complete and Return the Recall Effectiveness Check Form, even if no affected product is found, to your local Stryker Sustainability Sales Representative or email to [email protected] or mail to: Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ, 85283 Attn: Jodie Rueckert If you have any questions, contact Senior Director RA at 1(888)888-3433.
Quantity in commerce: 4 devices
Distribution: U.S. distribution to the following; AZ, MN and MO.
Product codes and lots: Item Number Serial Number Manufacturing Date 401940 1902898 3/31/2015 401940 1908621 3/31/2015 402004 1902392 1/9/2015 402004 1902389 1/9/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0380-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0380-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-09

Product code NLH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)