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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

201 linked reportsMalfunction 177Injury 24
24682019-01: 5 reports for this device; peer average 1.64/device2019-02: 1 reports for this device; peer average 1.52/device2019-03: 3 reports for this device; peer average 1.78/device2019-04: 0 reports for this device; peer average 1.69/device2019-05: 1 reports for this device; peer average 1.69/device2019-06: 5 reports for this device; peer average 1.57/device2019-07: 0 reports for this device; peer average 2.02/device2019-08: 0 reports for this device; peer average 2.38/device2019-09: 2 reports for this device; peer average 2.08/device2019-10: 0 reports for this device; peer average 2.24/device2019-11: 0 reports for this device; peer average 2.03/device2019-12: 1 reports for this device; peer average 2.52/device2020-01: 0 reports for this device; peer average 2.3/device2020-02: 1 reports for this device; peer average 2.95/device2020-03: 0 reports for this device; peer average 2.85/device2020-04: 1 reports for this device; peer average 2.16/device2020-05: 2 reports for this device; peer average 2.68/device2020-06: 1 reports for this device; peer average 2.49/device2020-07: 0 reports for this device; peer average 2.84/device2020-08: 2 reports for this device; peer average 2.54/device2020-09: 3 reports for this device; peer average 2.44/device2020-10: 4 reports for this device; peer average 2.65/device2020-11: 1 reports for this device; peer average 2.68/device2020-12: 1 reports for this device; peer average 2.75/device2021-01: 2 reports for this device; peer average 3.03/device2021-02: 1 reports for this device; peer average 2.16/device2021-03: 0 reports for this device; peer average 2.69/device2021-04: 3 reports for this device; peer average 2.62/device2021-05: 3 reports for this device; peer average 2.05/device2021-06: 3 reports for this device; peer average 2.42/device2021-07: 2 reports for this device; peer average 3.07/device2021-08: 2 reports for this device; peer average 2.39/device2021-09: 2 reports for this device; peer average 2.41/device2021-10: 4 reports for this device; peer average 2.02/device2021-11: 0 reports for this device; peer average 2.34/device2021-12: 2 reports for this device; peer average 2.64/device2022-01: 1 reports for this device; peer average 2.63/device2022-02: 0 reports for this device; peer average 2.35/device2022-03: 1 reports for this device; peer average 2.36/device2022-04: 1 reports for this device; peer average 2.61/device2022-05: 7 reports for this device; peer average 2.86/device2022-06: 4 reports for this device; peer average 2.75/device2022-07: 0 reports for this device; peer average 2.57/device2022-08: 5 reports for this device; peer average 3.01/device2022-09: 1 reports for this device; peer average 2.56/device2022-10: 4 reports for this device; peer average 2.26/device2022-11: 2 reports for this device; peer average 2.62/device2022-12: 1 reports for this device; peer average 2.42/device2023-01: 1 reports for this device; peer average 1.86/device2023-02: 5 reports for this device; peer average 2.64/device2023-03: 2 reports for this device; peer average 2.56/device2023-04: 6 reports for this device; peer average 2.25/device2023-05: 3 reports for this device; peer average 2.99/device2023-06: 6 reports for this device; peer average 2.39/device2023-07: 2 reports for this device; peer average 2.63/device2023-08: 3 reports for this device; peer average 2.65/device2023-09: 4 reports for this device; peer average 2.76/device2023-10: 3 reports for this device; peer average 2.54/device2023-11: 6 reports for this device; peer average 2.64/device2023-12: 4 reports for this device; peer average 2.8/device2024-01: 5 reports for this device; peer average 2.65/device2024-02: 1 reports for this device; peer average 2.63/device2024-03: 2 reports for this device; peer average 2.81/device2024-04: 7 reports for this device; peer average 2.26/device2024-05: 8 reports for this device; peer average 3.29/device2024-06: 5 reports for this device; peer average 3.05/device2024-07: 7 reports for this device; peer average 2.31/device2024-08: 4 reports for this device; peer average 3.62/device2024-09: 6 reports for this device; peer average 3.04/device2024-10: 1 reports for this device; peer average 4.01/device2024-11: 4 reports for this device; peer average 3.37/device2024-12: 0 reports for this device; peer average 3.81/device2025-01: 1 reports for this device; peer average 2.98/device2025-02: 0 reports for this device; peer average 3.19/device2025-03: 4 reports for this device; peer average 3.22/device2025-04: 1 reports for this device; peer average 3.49/device2025-05: 0 reports for this device; peer average 3.33/device2025-06: 2 reports for this device; peer average 2.89/device2025-07: 1 reports for this device; peer average 3.12/device2025-08: 2 reports for this device; peer average 3.21/device2025-09: 3 reports for this device; peer average 3.5/device2025-10: 1 reports for this device; peer average 3.24/device2025-11: 0 reports for this device; peer average 3.94/device2025-12: 0 reports for this device; peer average 4.49/device2026-01: 2 reports for this device; peer average 3.58/device2026-02: 0 reports for this device; peer average 3.79/device2026-03: 2 reports for this device; peer average 3.9/device2026-04: 1 reports for this device; peer average 2.99/device2026-05: 1 reports for this device; peer average 2.69/device2026-06: 0 reports for this device; peer average 2.84/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0151.64
2019-0211.52
2019-0331.78
2019-0401.69
2019-0511.69
2019-0651.57
2019-0702.02
2019-0802.38
2019-0922.08
2019-1002.24
2019-1102.03
2019-1212.52
2020-0102.3
2020-0212.95
2020-0302.85
2020-0412.16
2020-0522.68
2020-0612.49
2020-0702.84
2020-0822.54
2020-0932.44
2020-1042.65
2020-1112.68
2020-1212.75
2021-0123.03
2021-0212.16
2021-0302.69
2021-0432.62
2021-0532.05
2021-0632.42
2021-0723.07
2021-0822.39
2021-0922.41
2021-1042.02
2021-1102.34
2021-1222.64
2022-0112.63
2022-0202.35
2022-0312.36
2022-0412.61
2022-0572.86
2022-0642.75
2022-0702.57
2022-0853.01
2022-0912.56
2022-1042.26
2022-1122.62
2022-1212.42
2023-0111.86
2023-0252.64
2023-0322.56
2023-0462.25
2023-0532.99
2023-0662.39
2023-0722.63
2023-0832.65
2023-0942.76
2023-1032.54
2023-1162.64
2023-1242.8
2024-0152.65
2024-0212.63
2024-0322.81
2024-0472.26
2024-0583.29
2024-0653.05
2024-0772.31
2024-0843.62
2024-0963.04
2024-1014.01
2024-1143.37
2024-1203.81
2025-0112.98
2025-0203.19
2025-0343.22
2025-0413.49
2025-0503.33
2025-0622.89
2025-0713.12
2025-0823.21
2025-0933.5
2025-1013.24
2025-1103.94
2025-1204.49
2026-0123.58
2026-0203.79
2026-0323.9
2026-0412.99
2026-0512.69
2026-0602.84
This device (reports/month)Average device in DQX (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-04-23Z-1909-2024Class IIOpen, ClassifiedNeurovascular 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.Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.2859code info di
2024-04-18Z-1939-2024Class IIOpen, ClassifiedStryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.105,286code info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-05-143012931345-2026-00087MalfunctionAvailableexact di
2026-04-233012931345-2026-00077MalfunctionAvailableexact di
2026-03-253012931345-2026-00061MalfunctionAvailableexact di
2026-03-063012931345-2026-00043MalfunctionAvailableexact di
2026-01-303012931345-2026-00017MalfunctionAvailableexact di
2026-01-203012931345-2026-00011MalfunctionAvailableexact di
2025-10-173012931345-2025-00172MalfunctionAvailableexact di
2025-09-193012931345-2025-00154MalfunctionAvailableexact di
2025-09-163012931345-2025-00152MalfunctionAvailableexact di
2025-09-023012931345-2025-00147MalfunctionAvailableexact di
2025-08-063012931345-2025-00132MalfunctionAvailableexact di
2025-08-063012931345-2025-00133MalfunctionAvailableexact di
2025-07-103012931345-2025-00115MalfunctionAvailableexact di
2025-06-303012931345-2025-00111MalfunctionAvailableexact di
2025-06-263012931345-2025-00109MalfunctionAvailableexact di

Showing the most recent 200 of 201 linked reports.

Showing 1–15 of 200
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-06-18NAINo action indicatedInternational Life Sciences0
2026-02-20VAIVoluntary action indicatedStryker Puerto Rico, LLC2
2025-12-11NAINo action indicatedStryker Manufacturing Kalamazoo0
2025-05-22NAINo action indicatedStryker Macroom0
2025-03-27VAIVoluntary action indicatedStryker GmbH1
2025-03-27VAIVoluntary action indicatedStryker GmbH1
2025-02-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
2025-01-30NAINo action indicatedSerf0
2024-12-18VAIVoluntary action indicatedStryker Neurovascular1
2024-11-15VAIVoluntary action indicatedStryker Medical Division of Stryker Corporation2
2024-11-13NAINo action indicatedPOM Medical LLC0
2024-07-25VAIVoluntary action indicatedStryker Ireland, Ltd., Instruments Division1
2024-05-03NAINo action indicatedStryker Neurovascular, Inc.0
2024-04-18NAINo action indicatedPhysio-Control, Inc.0
2023-12-01VAIVoluntary action indicatedHowmedica Osteonics Corp.1
2023-05-15VAIVoluntary action indicatedLimFlow, Inc.2
2023-04-25NAINo action indicatedStryker Puerto Rico, LLC0
2023-01-24VAIVoluntary action indicatedStryker Corporation2
2023-01-24VAIVoluntary action indicatedStryker Corporation2
2022-03-08VAIVoluntary action indicatedPOM Medical LLC0
2017-04-06WLWarning LetterEntellus Medical Inc.—
2015-04-08WLWarning LetterThermedx LLC—
2013-11-26INJInjunctionPhysio-Control, Inc.—
2013-03-06WLWarning LetterStryker Corporation—
2013-03-06WLWarning LetterStryker Corporation—
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