Recall Z-1907-2024 ยท DQY Catheter, Percutaneous
Stryker Neurovascular
FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
| Date | May 28, 2024 (initiated Apr 23, 2024) |
| Status | Open, Classified |
| Reason | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. |
| Root cause | Process design |
| Action | On 4/23/24, recall notices were mailed to Supply Chain Management, Recall Coordinators, and Inventory Managers who were asked to do the following: 1) Cease further distribution or use of all affected devices. 2) Segregate the affected units in a secure location for return to the firm. 3) Circulate this Recall-Removal 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 the firm if any of the subject devices have been distributed to other organizations. If yes, |
| Quantity | 2579 |
| Distribution | Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153729 | 8F FlowGate2 Balloon Guide Catheter Concentric Medical, Jan 27, 2016 |