Recall Z-1708-2019 ยท DQY Catheter, Percutaneous
Stryker Neurovascular
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. Devi
| Date | Jun 2, 2019 (initiated Apr 18, 2019) |
| Status | Terminated |
| Reason | A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft. |
| Root cause | 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 organiza |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm Inneuroco, Inc., Dec 6, 2017 |