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.
158 linked reportsMalfunction 123Injury 35
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.64 |
| 2019-02 | 0 | 1.52 |
| 2019-03 | 1 | 1.78 |
| 2019-04 | 4 | 1.69 |
| 2019-05 | 0 | 1.69 |
| 2019-06 | 1 | 1.57 |
| 2019-07 | 1 | 2.02 |
| 2019-08 | 0 | 2.38 |
| 2019-09 | 0 | 2.08 |
| 2019-10 | 0 | 2.24 |
| 2019-11 | 1 | 2.03 |
| 2019-12 | 2 | 2.52 |
| 2020-01 | 1 | 2.3 |
| 2020-02 | 1 | 2.95 |
| 2020-03 | 1 | 2.85 |
| 2020-04 | 2 | 2.16 |
| 2020-05 | 2 | 2.68 |
| 2020-06 | 0 | 2.49 |
| 2020-07 | 0 | 2.84 |
| 2020-08 | 3 | 2.54 |
| 2020-09 | 2 | 2.44 |
| 2020-10 | 1 | 2.65 |
| 2020-11 | 0 | 2.68 |
| 2020-12 | 1 | 2.75 |
| 2021-01 | 2 | 3.03 |
| 2021-02 | 0 | 2.16 |
| 2021-03 | 1 | 2.69 |
| 2021-04 | 0 | 2.62 |
| 2021-05 | 0 | 2.05 |
| 2021-06 | 0 | 2.42 |
| 2021-07 | 1 | 3.07 |
| 2021-08 | 1 | 2.39 |
| 2021-09 | 1 | 2.41 |
| 2021-10 | 3 | 2.02 |
| 2021-11 | 3 | 2.34 |
| 2021-12 | 6 | 2.64 |
| 2022-01 | 3 | 2.63 |
| 2022-02 | 1 | 2.35 |
| 2022-03 | 2 | 2.36 |
| 2022-04 | 0 | 2.61 |
| 2022-05 | 2 | 2.86 |
| 2022-06 | 1 | 2.75 |
| 2022-07 | 1 | 2.57 |
| 2022-08 | 2 | 3.01 |
| 2022-09 | 1 | 2.56 |
| 2022-10 | 0 | 2.26 |
| 2022-11 | 1 | 2.62 |
| 2022-12 | 2 | 2.42 |
| 2023-01 | 3 | 1.86 |
| 2023-02 | 2 | 2.64 |
| 2023-03 | 0 | 2.56 |
| 2023-04 | 0 | 2.25 |
| 2023-05 | 4 | 2.99 |
| 2023-06 | 1 | 2.39 |
| 2023-07 | 2 | 2.63 |
| 2023-08 | 3 | 2.65 |
| 2023-09 | 2 | 2.76 |
| 2023-10 | 0 | 2.54 |
| 2023-11 | 3 | 2.64 |
| 2023-12 | 1 | 2.8 |
| 2024-01 | 2 | 2.65 |
| 2024-02 | 3 | 2.63 |
| 2024-03 | 4 | 2.81 |
| 2024-04 | 2 | 2.26 |
| 2024-05 | 3 | 3.29 |
| 2024-06 | 1 | 3.05 |
| 2024-07 | 2 | 2.31 |
| 2024-08 | 3 | 3.62 |
| 2024-09 | 1 | 3.04 |
| 2024-10 | 0 | 4.01 |
| 2024-11 | 1 | 3.37 |
| 2024-12 | 1 | 3.81 |
| 2025-01 | 7 | 2.98 |
| 2025-02 | 6 | 3.19 |
| 2025-03 | 5 | 3.22 |
| 2025-04 | 4 | 3.49 |
| 2025-05 | 3 | 3.33 |
| 2025-06 | 2 | 2.89 |
| 2025-07 | 3 | 3.12 |
| 2025-08 | 1 | 3.21 |
| 2025-09 | 1 | 3.5 |
| 2025-10 | 3 | 3.24 |
| 2025-11 | 1 | 3.94 |
| 2025-12 | 2 | 4.49 |
| 2026-01 | 1 | 3.58 |
| 2026-02 | 2 | 3.79 |
| 2026-03 | 7 | 3.9 |
| 2026-04 | 3 | 2.99 |
| 2026-05 | 4 | 2.69 |
| 2026-06 | 1 | 2.84 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-04-18 | Z-1941-2024 | Class II | Open, Classified | Stryker 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. | 373,246 | code info di |
| 2018-06-08 | Z-0229-2020 | Class II | Terminated | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.Distribution: Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK. | 21971 | code info di |
| 2010-06-07 | Z-0875-2011 | Terminated | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. | — | clearance family | |
| 2010-06-07 | Z-0871-2011 | Terminated | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. | — | clearance family | |
| 2010-06-07 | Z-0872-2011 | Terminated | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. | — | clearance family | |
| 2010-06-07 | Z-0873-2011 | Terminated | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. | — | clearance family | |
| 2010-06-07 | Z-0874-2011 | Terminated | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. | — | clearance family | |
| 2010-06-07 | Z-0868-2011 | Terminated | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. | — | clearance family | |
| 2010-06-07 | Z-0869-2011 | Terminated | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. | — | clearance family | |
| 2010-06-07 | Z-0870-2011 | Terminated | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system. | — | clearance family |
Showing 1–10 of 14
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-16 | 3012931345-2026-00102 | Malfunction | Available | exact di |
| 2026-05-19 | 3012931345-2026-00088 | Malfunction | Available | exact di |
| 2026-05-05 | 3012931345-2026-00081 | Malfunction | Available | exact di |
| 2026-05-04 | 3012931345-2026-00079 | Injury | Available | exact di |
| 2026-05-04 | 3012931345-2026-00080 | Malfunction | Available | exact di |
| 2026-04-16 | 3012931345-2026-00076 | Malfunction | Available | exact di |
| 2026-04-06 | 3012931345-2026-00070 | Malfunction | Available | exact di |
| 2026-04-02 | 3012931345-2026-00067 | Malfunction | Available | exact di |
| 2026-03-26 | 3012931345-2026-00062 | Malfunction | Available | exact di |
| 2026-03-20 | 3012931345-2026-00056 | Malfunction | Available | exact di |
| 2026-03-20 | 3012931345-2026-00053 | Malfunction | Available | exact di |
| 2026-03-20 | 3012931345-2026-00054 | Malfunction | Available | exact di |
| 2026-03-20 | 3012931345-2026-00057 | Malfunction | Available | exact di |
| 2026-03-19 | 3012931345-2026-00051 | Malfunction | Available | exact di |
| 2026-03-06 | 3012931345-2026-00041 | Malfunction | Available | exact di |
Showing the most recent 156 of 158 linked reports.
Showing 1–15 of 156
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-06-18 | NAI | No action indicated | International Life Sciences | 0 |
| 2026-02-20 | VAI | Voluntary action indicated | Stryker Puerto Rico, LLC | 2 |
| 2025-12-11 | NAI | No action indicated | Stryker Manufacturing Kalamazoo | 0 |
| 2025-05-22 | NAI | No action indicated | Stryker Macroom | 0 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-02-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2025-01-30 | NAI | No action indicated | Serf | 0 |
| 2024-12-18 | VAI | Voluntary action indicated | Stryker Neurovascular | 1 |
| 2024-11-15 | VAI | Voluntary action indicated | Stryker Medical Division of Stryker Corporation | 2 |
| 2024-11-13 | NAI | No action indicated | POM Medical LLC | 0 |
| 2024-07-25 | VAI | Voluntary action indicated | Stryker Ireland, Ltd., Instruments Division | 1 |
| 2024-05-03 | NAI | No action indicated | Stryker Neurovascular, Inc. | 0 |
| 2024-04-18 | NAI | No action indicated | Physio-Control, Inc. | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2023-05-15 | VAI | Voluntary action indicated | LimFlow, Inc. | 2 |
| 2023-04-25 | NAI | No action indicated | Stryker Puerto Rico, LLC | 0 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | POM Medical LLC | 0 |
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. | — |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC | — |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
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