Open, Classified

Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416 TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190

FDA Recall Z-1905-2024 · Posted 2024-05-28

Recall StatusOpen, Classified

Product CodePOL

Date Initiated2024-04-23

Product Quantity204

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.

Firm 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: [email protected]) 7) Complete and return the response form via email to [email protected]

Root Cause

Process design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223305Trevo NXT ProVue RetrieverStryker Neurovascular · 2023-03-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.