FlowGate2 neurovascular devices may exceed endotoxin limits due to inadequate testing
Stryker's FlowGate2 neurovascular devices may have excessive endotoxin levels because manufacturing failed to meet required testing standards. High endotoxin can cause fever, shock, and aseptic meningitis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with manufacturing non-compliance creating risk of serious complications (fever, shock, aseptic meningitis). No reported illnesses or injuries, and no hospitalization reports, qualify this as High severity per the rubric—a risk-of-harm product without yet-realized injury.
Plain-English summary
Stryker Neurovascular is recalling FlowGate2 8F neurovascular devices in two sizes: 8F x 85cm (Catalog 90485) and 8F x 95cm (Catalog 90495). Approximately 2,579 devices have been distributed worldwide, including throughout the United States and internationally.
During manufacturing, these devices did not receive the minimum sample size of endotoxin testing required by the AAMI ST72 standard. The devices are therefore out of compliance and may exceed acceptable endotoxin limits.
High levels of endotoxins in medical devices can increase the risk of fever, shock, and aseptic meningitis. Affected devices pose potential harm to patients who receive them.
The recalled product
- Product
- FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- endotoxin-contamination
- fever
- shock
- aseptic-meningitis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Catalog/UDI-DI/Lot: 90485/00815742004854/213869
- 90495/00815742004953/134165
- 134840
- 135021
- 138245
- 172663
- 172664
- 173281
- 175682
- 176460
- 176461
- 177614
- 178201
- 178720
- 213152
Distribution
Distributed nationwide across the United States.
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