Class 2 Device Recall Trevo XP ProVue Retriever

• Date Initiated by Firm: April 23, 2024
• Date Posted: May 28, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1907-2024
• Recall Event ID: 94437
• 510(K)Number: K153729
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
• Code Information: Catalog/UDI-DI/Lot: 90485/00815742004854/213869; 90495/00815742004953/134165, 134840, 135021, 138245, 172663, 172664, 173281, 175682, 176460, 176461, 177614, 178201, 178720, 213152
• Recalling Firm/ Manufacturer: Stryker Neurovascular; 47900 Bayside Pkwy; Fremont CA 94538-6515
• Manufacturer Reason for Recall: 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.
• FDA Determined 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, provide contact details so the firm can inform the recipients appropriately. 6) Inform the firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com) 7) Complete and return the response form via email to nvfieldactions@stryker.com
• Quantity in Commerce: 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, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DQY