Stryker Distal Access Catheter recalled for out-of-specification endotoxin contamination
Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This FDA Class II recall involves endotoxin contamination detected in a vascular catheter lot (43 units). Endotoxin in vascular devices poses serious risk of fever, inflammation, and systemic infection. Classified as High per rubric criterion: risk-of-harm medical device where injury has not been reported.
Plain-English summary
Stryker Neurovascular is recalling the Distal Access Catheter (DAC), model 038, 136cm. This device is a single-lumen, braided shaft catheter with a hydrophilic coating, used in neurovascular interventional procedures. A rotating hemostasis valve with side-arm adapter is provided with each catheter for aspiration, contrast injection, and direct arterial access.
The recall affects Lot 0000486382 (UDI-DI: 07613327313895), which was released with out-of-specification endotoxin results. Endotoxin is a bacterial toxin that can trigger fever, inflammation, and potentially serious systemic infection when introduced into the bloodstream.
A total of 43 units were distributed nationwide to hospitals and medical facilities in Texas, Florida, New Jersey, Colorado, Louisiana, North Carolina, Alabama, Pennsylvania, Michigan, Mississippi, South Carolina, and Illinois. The FDA classified this as a Class II recall requiring removal of the product from distribution.
Healthcare providers and hospitals that received this product should immediately discontinue use and quarantine any remaining units from Lot 0000486382 (expiration date July 17, 2025). Affected facilities should contact Stryker Neurovascular for return authorization and replacement units.
The recalled product
- Product
- The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration…
- Manufacturer
- Stryker Neurovascular
- Hazard
- Affected units
- 43
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 (3)
- UDI-DI: 07613327313895
- Lot: 0000486382
- Expiration: 17-Jul-2025
Distribution
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