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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Neurovascular

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  Class 2 Device Recall Stryker Neurovascular see related information
Date Initiated by Firm April 18, 2019
Create Date June 02, 2019
Recall Status1 Open3, Classified
Recall Number Z-1708-2019
Recall Event ID 82755
510(K)Number K172468  
Product Classification Catheter, percutaneous - Product Code DQY
Product Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876):

a) REF: INC-11196-70, 70cm,
b) REF: INC-11196-80, 80cm,
c) REF: INC-11196-90, 90cm

Product Usage:
Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. Device Description: The AXS Infinity LS Plus Long Sheath is a single lumen, flexible, variable stiffness long sheath with an 0.091 inch inner diameter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Infinity LS Plus Long Sheath shaft has a 10 cm lubricious coating at the distal end to reduce friction during use. The inner lumen of the AXS Infinity LS Plus Long Sheath is compatible with 6F or smaller catheters. Each package includes one AXS Infinity LS Plus Long Sheath (INC- 11196-70, INC-11196-80, or INC-11196-90), one Dilator, and one hemostasis valve. Dimensions of the AXS Infinity LS Plus Long Sheath are included on the individual device label.
Code Information All lots
Recalling Firm/
Manufacturer
Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
Manufacturer Reason
for Recall
A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
FDA Determined
Cause 2
Device Design
Action On 04/18/19, Urgent Medical Device Voluntary Recall-Removal notices were sent to customers via overnight delivery. Customers were asked to do the following: 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to firm. 3. Circulate this Field Safety Notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform recalling firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that the recalling firm can inform the recipients appropriately. 6. Please inform the recalling firm of any adverse events concerning the use of the subject devices. 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 8. Email the completed form to NVCustomerCare@Stryker.com 9. Product Return Information will be provided to you by your designated Territory Manager or Sales Representative. In addition, If you have loaned or sold any of the units listed, please, forward a copy of this notice to the new users and advise the recalling firm of their new location.
Quantity in Commerce 2435
Distribution U.S Nationwide Distribution - PA, VA, TX, CA, FL, AR, TN, MI, NY, IL, NC, KY, WV, OH, MO, AZ, GA, WA, VT, DC, SC, NJ, MN, OK, MD, AL, LA, MA, DE, IN, OR, RI, SD, MS, WI, ID, UT, CO, IA, KS, CT, NE, NM
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = InNeuroCo, Inc
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