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FlowGate2 recallZ-1907-2024 · Stryker Neurovascular · initiated Apr 23, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process design

What the company is doing

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]

Recall details

Recall number
Z-1907-2024
Status
Open, Classified
Initiated by the company
Apr 23, 2024
Posted by the FDA
May 28, 2024
Recalling firm
Stryker Neurovascular
Quantity
2579
Product code
DQY
FDA submissions
K153729
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.

Product description

FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495

Code information (models, lots, serial numbers)

Catalog/UDI-DI/Lot: 90485/00815742004854/213869; 90495/00815742004953/134165, 134840, 135021, 138245, 172663, 172664, 173281, 175682, 176460, 176461, 177614, 178201, 178720, 213152

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94437).

Sources and updates

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