Reported Jun 5, 2024 · Ongoing
Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT…
Stryker Neurovascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515
Is this the product you have?
- Trevo NXT ProVue 3 x 32, US
- Catalog90312
- KitsTREVO NXT 3X32+TRAK21 2-PACK - CE
- Catalog91412 TREVO NXT 4X28+TRAK21 2-PACK - CE
- Catalog91413 TREVO NXT 4X41+TRAK21 2-PACK - CE
- Catalog91414 TREVO NXT 6X37+TRAK21 2-PACK - CE
- Catalog91415 TREVO NXT 3X32+PRO14 2-PACK - CE
- Catalog91416 TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE
- CatalogSFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE
- CatalogSFP914190
- Lot codes and dates
8 of 8 products · 118 lot codes
Recalled lot codes, grouped by product number Catalog UDI-DI Lot 9031207613327299922118881
914120761332750068448483279484832814848329448696618486966194869662048715713488346924883469548834696
91413076133275006914848328048483284484832894848329148483316484833174869661348696622486966234871571148715715
91414076133275007074844777648447778484477794848329048483292484832934848331548483318484833204869662448715714488346904883469148834694488346974885272648852730488527314885273248852734488527354885273748852738
9141507613327500714484832774848328348483295484832964848331148483312486966214871571248715716488346884883469348834698
91416076133275079044732886347328865473518154735181647374814485009884850100648501007485010084850100948501010485010114850101248501013485010144854027748556780485567834855837548588482485898764864152450065509500655205019357250260581503273855032740350375186503751875042257750422588504482745073889250762691507627215076272250786687507974915079749450797495508865085132049051320491513793945137939951379400513794015137940251379403513794045137940551379406513794085146792751489221514892305148923351489234
SFP9141700761332750805548834689
SFP9141900761332750807948945914
- Amount recalled
- 204
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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