Neurovascular devices recalled due to inadequate endotoxin testing
Stryker Neurovascular is recalling 81 neurovascular devices due to inadequate endotoxin testing. The devices may contain excessive endotoxin levels, which can cause fever, shock, and aseptic meningitis.
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 is an FDA Class II recall for a medical device with potential to cause serious harm including fever, shock, and aseptic meningitis. No illnesses or injuries have been reported. The hazard is theoretical—the devices may exceed acceptable endotoxin limits but actual patient impact has not been documented.
Plain-English summary
Stryker Neurovascular is recalling 81 DAC 044 115cm neurovascular devices (Catalog 90760, Lot 156628). The devices were distributed worldwide to healthcare facilities in the United States and internationally.
The devices did not meet the minimum sample size required for endotoxin testing during manufacturing and do not comply with the AAMI ST72 standard. This means the devices may exceed acceptable limits of endotoxin levels.
High levels of endotoxins can increase the risk of fever, shock, and aseptic meningitis. Healthcare providers who have received these devices should contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- DAC 044 115cm, Catalog: 90760
- Manufacturer
- Stryker Neurovascular
- Affected units
- 81
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)
- Catalog: 90760
- UDI-DI: 07613327313918
- Lot: 156628
Distribution
Part of a larger recall action
This product is one of 8 recalled by Stryker Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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