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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker Neurovascular: Neurovascular Devices Recalled for Potential Endotoxin Contamination

Agency Publication Date: May 28, 2024
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Summary

Stryker Neurovascular is recalling approximately 8,011 neurovascular devices, including various Trevo retrievers, microcatheters, guide wires, and FlowGate kits. These devices did not meet the required testing standards for endotoxins during manufacturing, which means they may contain levels of bacterial toxins that exceed safety limits. This recall affects a wide range of surgical equipment used in neurovascular procedures worldwide.

Risk

Exposure to high levels of endotoxins through these medical devices can trigger a dangerous immune response. This may lead to high fever, septic shock, and aseptic meningitis (inflammation of the brain lining), posing a serious health risk during or after surgery.

What You Should Do

  1. Identify if you have any of the affected Stryker Neurovascular devices by checking the catalog and lot numbers on the product packaging, such as Trevo XP ProVue Retriever (Catalog 90182, 90183, 90185, 90186), Trevo ProVue (Catalog 90184), or FlowGate2 (Catalog 90485, 90495).
  2. Verify specific lot codes against the extensive list provided, such as lot 116706 for Catalog 90182, or lot 156628 for the DAC 044 (Catalog 90760).
  3. Immediately stop using any devices identified as part of the recalled lots and quarantine them to prevent clinical use.
  4. Contact your healthcare provider or Stryker Neurovascular directly at 1-888-463-6332 to discuss the next steps for returning the affected products and obtaining replacements.
  5. Healthcare facilities should follow the instructions provided in the manufacturer's notification letter regarding the return and potential refund for these medical devices.
  6. For additional questions or to report a related health issue, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and professional consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Trevo XP ProVue Retriever 4 x 20
Model / REF:
90182
UPC Codes:
00815742001822
Lot Numbers:
116706
Product: Trevo XP ProVue Retriever 3 x 20
Model / REF:
90183
UPC Codes:
00815742001839
Lot Numbers:
117514
Product: Trevo XP ProVue Retriever 4 x 30
Model / REF:
90185
UPC Codes:
00815742001853
Lot Numbers:
118900
Product: Trevo XP ProVue Retriever 6 x 25
Model / REF:
90186
UPC Codes:
00815742001860
Lot Numbers:
114054
Product: TREVO XP 3X20+PRO14 2-PACK Kit
Model / REF:
80051
UPC Codes:
00815742000511
Lot Numbers (102):
47307561
47328877
47351811
47398058
47398074
48521577
48521585
48540280
48540281
48540282
48540283
48540284
48556786
48588490
48607589
48676218
48696629
48715720
48736116
48736122
48754915
48754920
48772012
48772014
48772025
50065499
50065511
50065512
50065513
50065514
50065515
50065518
50113384
50113385
50133176
50133191
50193582
50216273
50216274
50216277
50239676
50260575
50260583
50280979
50281011
50304688
50304712
50304713
50304714
50397877
Product: Trevo ProVue
Model / REF:
90184
UPC Codes:
00815742001846
Lot Numbers:
118117
118420
118833
Product: Trevo Pro 14 Microcatheter
Model / REF:
90231
UPC Codes:
00815742002317
Lot Numbers:
121050
129849
129882
130285
136439
136628
143375
143476
Product: Trevo Pro 18 Microcatheter
Model / REF:
90238
UPC Codes:
00815742002386
Lot Numbers:
136009
198334
Product: Trevo NXT ProVue 3 x 32, US
Model / REF:
90312
UPC Codes:
07613327299922
Lot Numbers:
118881
Product: Trevo Trak 21 Microcatheter
Model / REF:
90338
UPC Codes:
07613327313956
Lot Numbers:
119461
119473
119598
120070
120201
120970
140512
136912
136913
136914
136915
Product: FlowGate2 8F x 85cm
Model / REF:
90485
UPC Codes:
00815742004854
Lot Numbers:
213869
Product: FlowGate2 8F x 95cm
Model / REF:
90495
UPC Codes:
00815742004953
Lot Numbers:
134165
134840
135021
138245
172663
172664
173281
175682
176460
176461
177614
178201
178720
213152
Product: DAC 044 115cm
Model / REF:
90760
UPC Codes:
07613327313918
Lot Numbers:
156628
Product: Synchro .014 guide wire, 35 cm tip
Model / REF:
M00313010
UPC Codes:
07613252186922
Lot Numbers:
123279
123364
123404
123985
124214
124216
Product: SYNCHRO .010 WIRE SOFT STRAIGHT 200cm
Model / REF:
M00316310
UPC Codes:
07613252187158
Lot Numbers:
123851

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94437
Status: Active
Manufacturer: Stryker Neurovascular
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 8 products (461; 280; 648; 204; 899; 2579; 81; 2859)
Distributed To: Minnesota, Pennsylvania, Illinois, Alaska, New York, California, Michigan, Wisconsin, Texas, Arizona, Florida, Kentucky, Massachusetts, Indiana, Nebraska, Montana, Connecticut, New Jersey, Tennessee, Virginia, Alabama, Colorado, Delaware, Ohio, Utah, North Carolina, Maine, Georgia, South Carolina, Guam, Washington, Missouri, Oregon, District of Columbia, Oklahoma, Louisiana, Maryland, Idaho, New Hampshire, South Dakota, Nevada, Rhode Island, North Dakota, Hawaii, Mississippi, Arkansas, Iowa, New Mexico, Vermont, Kansas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.