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U.S. Department of Health and Human Services

Class 2 Device Recall Daig Livewire Steerable and Supreme Fixed Curve Diagnostic Electrophysiology Catheters

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 Class 2 Device Recall Daig Livewire Steerable and Supreme Fixed Curve Diagnostic Electrophysiology Catheterssee related information
Date Initiated by FirmOctober 06, 2016
Create DateNovember 09, 2016
Recall Status1 Terminated 3 on December 16, 2016
Recall NumberZ-0380-2017
Recall Event ID 75409
510(K)NumberK012708 K042074 
Product Classification Catheter, recording, electrode, reprocessed - Product Code NLH
ProductReprocessed 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.
Code Information 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
FEI Number 3009350690
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact
888-888-3433
Manufacturer Reason
for Recall		The EP Catheters may be mislabeled for French size during reprocessing.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 SSSPFA@stryker.com 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 Commerce4 devices
DistributionU.S. distribution to the following; AZ, MN and MO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NLH
510(K)s with Product Code = NLH
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