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.
32 linked reportsMalfunction 27Injury 4Other 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.42 |
| 2019-02 | 0 | 3.53 |
| 2019-03 | 0 | 2.95 |
| 2019-04 | 0 | 3.13 |
| 2019-05 | 0 | 2.46 |
| 2019-06 | 0 | 3.58 |
| 2019-07 | 0 | 2.42 |
| 2019-08 | 0 | 2.47 |
| 2019-09 | 0 | 2.47 |
| 2019-10 | 0 | 2.71 |
| 2019-11 | 0 | 2.12 |
| 2019-12 | 0 | 2.35 |
| 2020-01 | 0 | 2.55 |
| 2020-02 | 0 | 2.7 |
| 2020-03 | 0 | 2.28 |
| 2020-04 | 0 | 2.54 |
| 2020-05 | 0 | 1.98 |
| 2020-06 | 1 | 2.78 |
| 2020-07 | 0 | 2.77 |
| 2020-08 | 0 | 4.33 |
| 2020-09 | 0 | 4.4 |
| 2020-10 | 0 | 3.99 |
| 2020-11 | 0 | 4.47 |
| 2020-12 | 3 | 3.87 |
| 2021-01 | 0 | 3.99 |
| 2021-02 | 1 | 3.89 |
| 2021-03 | 0 | 4.83 |
| 2021-04 | 0 | 4.7 |
| 2021-05 | 0 | 4.05 |
| 2021-06 | 0 | 4.28 |
| 2021-07 | 0 | 3.88 |
| 2021-08 | 1 | 3.87 |
| 2021-09 | 0 | 3.91 |
| 2021-10 | 0 | 3.99 |
| 2021-11 | 0 | 3.49 |
| 2021-12 | 0 | 4.46 |
| 2022-01 | 0 | 4.57 |
| 2022-02 | 0 | 5.03 |
| 2022-03 | 0 | 5.45 |
| 2022-04 | 0 | 6.48 |
| 2022-05 | 0 | 5.46 |
| 2022-06 | 0 | 6.07 |
| 2022-07 | 0 | 6.34 |
| 2022-08 | 0 | 6.38 |
| 2022-09 | 2 | 5.53 |
| 2022-10 | 0 | 5.35 |
| 2022-11 | 0 | 5.52 |
| 2022-12 | 0 | 6 |
| 2023-01 | 2 | 5.73 |
| 2023-02 | 1 | 4.87 |
| 2023-03 | 0 | 5.86 |
| 2023-04 | 2 | 5.47 |
| 2023-05 | 0 | 5.86 |
| 2023-06 | 0 | 7.1 |
| 2023-07 | 0 | 6.1 |
| 2023-08 | 0 | 6.28 |
| 2023-09 | 1 | 5.92 |
| 2023-10 | 0 | 6.38 |
| 2023-11 | 1 | 5.76 |
| 2023-12 | 3 | 6.05 |
| 2024-01 | 1 | 5.53 |
| 2024-02 | 0 | 6.18 |
| 2024-03 | 0 | 5.56 |
| 2024-04 | 0 | 6.32 |
| 2024-05 | 1 | 5.3 |
| 2024-06 | 2 | 7.07 |
| 2024-07 | 3 | 5.75 |
| 2024-08 | 0 | 6.5 |
| 2024-09 | 1 | 6.28 |
| 2024-10 | 0 | 7.11 |
| 2024-11 | 0 | 4.55 |
| 2024-12 | 1 | 4.77 |
| 2025-01 | 0 | 4.42 |
| 2025-02 | 0 | 4.03 |
| 2025-03 | 0 | 5.17 |
| 2025-04 | 0 | 4.67 |
| 2025-05 | 1 | 4.69 |
| 2025-06 | 0 | 4.58 |
| 2025-07 | 0 | 4.68 |
| 2025-08 | 0 | 5.45 |
| 2025-09 | 0 | 3.97 |
| 2025-10 | 0 | 4.59 |
| 2025-11 | 2 | 4.86 |
| 2025-12 | 1 | 6.15 |
| 2026-01 | 0 | 4.95 |
| 2026-02 | 0 | 5.05 |
| 2026-03 | 0 | 5.77 |
| 2026-04 | 0 | 6.2 |
| 2026-05 | 0 | 5.86 |
| 2026-06 | 1 | 5.01 |
Failure-mode summaryAI-generated
32 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-05-14 | Z-2473-2026 | Class II | Open, Classified | Potential for overpressure alerts.Distribution: Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. . | 71,151 packs (426,908 eaches) | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-04 | 3007305485-2026-00119 | Malfunction | Available | catalog number |
| 2025-12-18 | 3007305485-2025-00208 | Malfunction | Available | catalog number |
| 2025-11-26 | 3007305485-2025-00191 | Malfunction | Available | catalog number |
| 2025-05-01 | 3007305485-2025-00080 | Injury | Available | exact di |
| 2024-12-16 | 3007305485-2024-00194 | Malfunction | Available | exact di |
| 2024-09-23 | 3007305485-2024-00140 | Injury | Available | exact di |
| 2024-07-30 | 3007305485-2024-00110 | Malfunction | Available | exact di |
| 2024-07-24 | MW5157585 | Other | Available | model number |
| 2024-07-24 | 3007305485-2024-00105 | Malfunction | Available | exact di |
| 2024-06-06 | 19475324 | Malfunction | Available | catalog number |
| 2024-05-06 | 1320894-2024-00120 | Malfunction | Available | exact di |
| 2024-01-02 | 3007305485-2024-00001 | Malfunction | Available | exact di |
| 2023-12-13 | 18323517 | Malfunction | Available | catalog number |
| 2023-11-16 | 3007305485-2023-00240 | Injury | Available | exact di |
| 2023-09-28 | 3007305485-2023-00209 | Malfunction | Available | exact di |
Showing the most recent 25 of 32 linked reports.
Showing 1–15 of 25
Regulatory clearances
Predicate lineage
- K230239
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-05-13 | NAI | No action indicated | Biorez, Inc | 0 |
| 2026-04-06 | VAI | Voluntary action indicated | ConMed Corporation | 6 |
| 2026-04-06 | VAI | Voluntary action indicated | ConMed Corporation | 6 |
| 2023-12-14 | NAI | No action indicated | Linvatec Corp. | 0 |
| 2023-08-04 | VAI | Voluntary action indicated | Biorez, Inc | 1 |
| 2022-11-10 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-11-10 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-07-13 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-07-13 | NAI | No action indicated | ConMed Corporation | 0 |
| 2020-09-22 | VAI | Voluntary action indicated | ConMed Corporation | 0 |
| 2020-09-22 | VAI | Voluntary action indicated | ConMed Corporation | 0 |
| 2019-10-17 | NAI | No action indicated | ConMed Corporation | 0 |
| 2019-10-17 | NAI | No action indicated | ConMed Corporation | 0 |
| 2017-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 2 |
| 2017-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 2 |
| 2017-01-23 | NAI | No action indicated | Conmed | 0 |
| 2016-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 5 |
| 2016-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 5 |
| 2014-11-18 | NAI | No action indicated | ConMed Corporation | 0 |
| 2014-11-18 | NAI | No action indicated | ConMed Corporation | 0 |
| 2014-01-29 | WL | Warning Letter | ConMed Corporation | — |
| 2014-01-29 | WL | Warning Letter | ConMed Corporation | — |
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