Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx… recallZ-1708-2019 · Stryker Neurovascular · initiated Apr 18, 2019

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.

FDA root cause category: Device Design

What the company is doing

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 [email protected] 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.

Recall details

Recall number

Z-1708-2019

Recall class

Class II

Status

Terminated

Initiated by the company

Apr 18, 2019

Posted by the FDA

Jun 2, 2019

Recalling firm

Stryker Neurovascular

Quantity

2435

Product code

DQY

FDA submissions

K172468

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

Product description

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.

Other devices under the same FDA submission

3 devices cleared under K172468 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• AXS INFINITY LS PLUS INC-11196-90

  Stryker Corporation · Catheter, percutaneous
  26 reports
• AXS INFINITY LS PLUS INC-11196-70

  Stryker Corporation · Catheter, percutaneous
  2 reports
• AXS INFINITY LS PLUS INC-11196-80

  Stryker Corporation · Catheter, percutaneous
  2 reports