—#172635

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K172468
Affected lot / code info: All lots

Why it was recalled

A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-04-18
Posted by FDA: 2019-06-02
Terminated: 2021-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172635. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.