Trevo XP ProVue neurovascular retriever devices recalled for inadequate endotoxin testing
Stryker Neurovascular's Trevo XP ProVue Retriever devices did not undergo adequate endotoxin testing and may exceed safe limits, potentially causing 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: The recall involves high-risk biological hazards with potential for serious clinical consequences (fever, shock, aseptic meningitis), meeting the rubric criterion for risk-of-harm products where injury has not yet been reported. Since no illnesses or injuries are reported in the source text and the hazard is theoretical based on potential endotoxin limits, the maximum applicable score is 3.
Plain-English summary
Stryker Neurovascular is recalling its Trevo XP ProVue Retriever neurovascular devices and related kits, which are used in interventional medical procedures.
The devices did not meet the minimum sample size required for endotoxin testing during manufacturing and are out of compliance with the AAMI ST72 standard. As a result, these devices may exceed acceptable endotoxin levels.
High endotoxin levels can increase the risk of fever, shock, and aseptic meningitis when these devices are used clinically.
The affected devices have been distributed worldwide, including throughout the United States and multiple countries. Healthcare providers and patients should contact Stryker Neurovascular if they have received affected units, using the provided catalog and lot numbers for identification.
The recalled product
- Product
- Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18…
- Manufacturer
- Stryker Neurovascular
- Affected units
- 461
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 (20)
- Catalog/UDI-DI/Lot: 90182/00815742001822/116706
- 90183/00815742001839/117514
- 90185/00815742001853/118900
- 90186/00815742001860/114054
- 80051/00815742000511/47307561
- 47328877
- 47351811
- 47398058
- 47398074
- 48521577
- 48521585
- 48540280
- 48540281
- 48540282
- 48540283
- 48540284
- 48556786
- 48588490
- 48607589
- 48676218
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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