Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-387
FDA device recall Z-1708-2019 · posted 2019-06-02 · Terminated
Recall details
- Recalling firm
- Stryker Neurovascular
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 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
- Date initiated
- 2019-04-18
- Date posted
- 2019-06-02
- Date terminated
- 2021-04-27
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (K172468) | Inneuroco, Inc. | 2017-12-06 |