Reported Jun 5, 2024 · Ongoing
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue…
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 XP ProVue Retriever 4 x 20
- Catalog90182 Trevo XP ProVue Retriever 3 x 20
- Catalog90183 Trevo XP ProVue Retriever 4 x 30
- Catalog90185 Trevo XP ProVue Retriever 6 x 25
- Catalog90186
- KitsTREVO XP 3X20+PRO14 2-PACK
- Catalog80051 TREVO XP 4X20+PRO18 2-PACK
- Catalog80052 TREVO XP 4X30+PRO18 2-PACK
- Catalog93067 TREVO XP 6X25+XT27 2-PACK
- Catalog93068 TREVO XP 3X20+PRO14+CAT6 3-PACK - CE
- CatalogM0033PK32021002 TREVO XP 4X20+PRO18+CAT6 3-PACK - CE
- CatalogM0033PK42022002 TREVO XP 6X25+XT27+CAT6 3-PACK - CE
- CatalogM0033PK62523002
- Lot codes and dates
11 of 11 products · 162 lot codes
Recalled lot codes, grouped by product number Catalog UDI-DI Lot 9018200815742001822116706
9018300815742001839117514
9018500815742001853118900
9018600815742001860114054
8005100815742000511473075614732887747351811473980584739807448521577485215854854028048540281485402824854028348540284485567864858849048607589486762184869662948715720487361164873612248754915487549204877201248772014487720255006549950065511500655125006551350065514500655155006551850113384501133855013317650133191501935825021627350216274502162775023967650260575502605835028097950281011503046885030471250304713503047145039787750422572504225825042258950448279505192745051927550519276505192775051928550519295505775725060737450607376506073775060737850650278506502795065028850673881506738845067390850673909506739105067391150673930506942795073891250786710508506975086988750869892508699055088648750912493509125145091251550912516509125175093149050931518509315195095040250967093513204975135050351350505514892285148923551513311515135165153542151729133
8005200815742000528490211144902111549021116490211174902111849033114490331154903311649033117490525174905252549192125491921404919214149216723492167244921673753175402
930670081574200067253320201
9306800815742000689489633134905631549155966492167254931883149318836493188374941874049418743494413465000093250000933500009345002933350029340500293615004705450065482500654855006548650065487
M0033PK3202100207613327126334485009904862422648641523486415335015637250519272506502905091251350967091
M0033PK420220020761332712635848995917490331234914062449236926
- Amount recalled
- 461
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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