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.
271 linked reportsMalfunction 268Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 1.5 |
| 2019-02 | 4 | 4 |
| 2019-03 | 0 | 3 |
| 2019-04 | 1 | 1 |
| 2019-05 | 4 | 2 |
| 2019-06 | 1 | 1.38 |
| 2019-07 | 0 | 1 |
| 2019-08 | 2 | 1.5 |
| 2019-09 | 0 | 1.5 |
| 2019-10 | 1 | 2.2 |
| 2019-11 | 1 | 1.8 |
| 2019-12 | 0 | 1.57 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 1 |
| 2020-03 | 2 | 2 |
| 2020-04 | 0 | 1 |
| 2020-06 | 0 | 1 |
| 2020-07 | 8 | 3.5 |
| 2020-08 | 0 | 1.67 |
| 2020-09 | 3 | 2.33 |
| 2020-10 | 0 | 2.5 |
| 2020-11 | 2 | 2.4 |
| 2020-12 | 1 | 1.25 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 3 |
| 2021-03 | 0 | 2.33 |
| 2021-04 | 8 | 3.5 |
| 2021-05 | 0 | 3 |
| 2021-06 | 3 | 2 |
| 2021-07 | 3 | 2.67 |
| 2021-08 | 1 | 1 |
| 2021-09 | 0 | 1.33 |
| 2021-10 | 0 | 2 |
| 2021-11 | 1 | 2.4 |
| 2021-12 | 2 | 1.25 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 2 | 1.2 |
| 2022-04 | 3 | 3.2 |
| 2022-05 | 2 | 1.75 |
| 2022-06 | 0 | 1.5 |
| 2022-07 | 1 | 1 |
| 2022-08 | 1 | 1 |
| 2022-09 | 1 | 1.6 |
| 2022-10 | 0 | 1.4 |
| 2022-11 | 1 | 1.57 |
| 2022-12 | 1 | 1 |
| 2023-01 | 0 | 1 |
| 2023-02 | 7 | 2.5 |
| 2023-03 | 1 | 1 |
| 2023-04 | 1 | 1.25 |
| 2023-05 | 0 | 1.4 |
| 2023-06 | 2 | 1.33 |
| 2023-07 | 1 | 1.33 |
| 2023-08 | 2 | 1.5 |
| 2023-10 | 0 | 1.57 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-01 | 3 | 2.17 |
| 2024-02 | 7 | 5 |
| 2024-03 | 2 | 1.2 |
| 2024-04 | 0 | 1.5 |
| 2024-05 | 0 | 1 |
| 2024-06 | 1 | 1.8 |
| 2024-07 | 1 | 1 |
| 2024-09 | 5 | 2.33 |
| 2024-10 | 1 | 1.5 |
| 2024-11 | 3 | 2.33 |
| 2024-12 | 0 | 1 |
| 2025-01 | 0 | 1.25 |
| 2025-02 | 5 | 2.4 |
| 2025-03 | 30 | 6 |
| 2025-04 | 41 | 7 |
| 2025-05 | 22 | 7.14 |
| 2025-06 | 23 | 10 |
| 2025-07 | 3 | 2.6 |
| 2025-08 | 17 | 5 |
| 2025-09 | 5 | 2.4 |
| 2025-10 | 3 | 4.17 |
| 2025-11 | 3 | 4 |
| 2025-12 | 3 | 3.2 |
| 2026-01 | 0 | 1 |
| 2026-02 | 3 | 3.5 |
| 2026-03 | 4 | 2.33 |
| 2026-04 | 3 | 2.5 |
| 2026-05 | 0 | 7.5 |
| 2026-06 | 7 | 3 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-06-18 | Z-2171-2025 | Class II | Open, Classified | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea. | N/A | code info di |
| 2017-11-17 | Z-0835-2018 | Class II | Terminated | Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.Distribution: Distributed domestically to . Distributed internationally to Australia and Mexico. | 60,753 units total | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-30 | 0002936485-2026-00428 | Malfunction | — | exact di |
| 2026-06-30 | 0002936485-2026-00427 | Malfunction | — | exact di |
| 2026-06-30 | 0002936485-2026-00426 | Malfunction | — | exact di |
| 2026-06-30 | 0002936485-2026-00424 | Malfunction | Available | exact di |
| 2026-06-29 | 0002936485-2026-00420 | Malfunction | — | exact di |
| 2026-06-26 | 0002936485-2026-00414 | Malfunction | — | exact di |
| 2026-06-24 | 0002936485-2026-00400 | Malfunction | Available | exact di |
| 2026-04-17 | 24910242 | Malfunction | Available | catalog number |
| 2026-04-02 | 0002936485-2026-00220 | Malfunction | Available | exact di |
| 2026-03-24 | 24673296 | Malfunction | Available | catalog number |
| 2026-03-19 | 0002936485-2026-00164 | Malfunction | Available | exact di |
| 2026-03-19 | 0002936485-2026-00165 | Malfunction | Available | exact di |
| 2026-02-18 | 0002936485-2026-00099 | Malfunction | Available | exact di |
| 2026-02-09 | 0002936485-2026-00072 | Injury | Available | exact di |
| 2026-02-09 | 0002936485-2026-00073 | Injury | Available | exact di |
Showing the most recent 200 of 271 linked reports.
Showing 1–15 of 200
Regulatory clearances
None linked.
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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