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.
9 linked reportsMalfunction 6Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 15.5 |
| 2019-03 | 0 | 29 |
| 2019-04 | 0 | 15 |
| 2019-05 | 0 | 11.67 |
| 2019-06 | 0 | 14.33 |
| 2019-07 | 0 | 10.33 |
| 2019-08 | 0 | 15.67 |
| 2019-09 | 0 | 8.2 |
| 2019-10 | 0 | 15.33 |
| 2019-11 | 0 | 14.67 |
| 2019-12 | 0 | 13.25 |
| 2020-01 | 0 | 22 |
| 2020-02 | 0 | 20 |
| 2020-03 | 0 | 20.5 |
| 2020-04 | 0 | 34 |
| 2020-05 | 0 | 6 |
| 2020-06 | 0 | 6.7 |
| 2020-07 | 0 | 7.57 |
| 2020-08 | 0 | 8.33 |
| 2020-09 | 0 | 10.4 |
| 2020-10 | 0 | 6.55 |
| 2020-11 | 0 | 10.33 |
| 2020-12 | 0 | 8.71 |
| 2021-01 | 0 | 6.67 |
| 2021-02 | 0 | 5.71 |
| 2021-03 | 0 | 7.4 |
| 2021-04 | 0 | 9.17 |
| 2021-05 | 0 | 7.67 |
| 2021-06 | 0 | 6.78 |
| 2021-07 | 0 | 6.2 |
| 2021-08 | 0 | 10.4 |
| 2021-09 | 0 | 11.8 |
| 2021-10 | 0 | 9.75 |
| 2021-11 | 0 | 5.5 |
| 2021-12 | 0 | 8.25 |
| 2022-01 | 0 | 15.5 |
| 2022-02 | 0 | 4.36 |
| 2022-03 | 0 | 8.14 |
| 2022-04 | 0 | 7.4 |
| 2022-05 | 2 | 6 |
| 2022-06 | 0 | 10.17 |
| 2022-07 | 0 | 14 |
| 2022-08 | 0 | 6.63 |
| 2022-09 | 0 | 14 |
| 2022-10 | 0 | 9.33 |
| 2022-11 | 2 | 8.17 |
| 2022-12 | 0 | 11.75 |
| 2023-01 | 0 | 10 |
| 2023-02 | 0 | 8.2 |
| 2023-03 | 1 | 8.25 |
| 2023-04 | 0 | 9 |
| 2023-05 | 0 | 10.75 |
| 2023-06 | 0 | 11.2 |
| 2023-07 | 0 | 9.67 |
| 2023-08 | 1 | 6.67 |
| 2023-09 | 1 | 6.4 |
| 2023-10 | 0 | 7.25 |
| 2023-11 | 0 | 14 |
| 2023-12 | 0 | 6.25 |
| 2024-01 | 0 | 14.75 |
| 2024-02 | 0 | 5.6 |
| 2024-03 | 0 | 7.75 |
| 2024-04 | 0 | 5.2 |
| 2024-05 | 0 | 3.6 |
| 2024-06 | 0 | 7 |
| 2024-07 | 0 | 5.17 |
| 2024-08 | 0 | 5 |
| 2024-09 | 0 | 8 |
| 2024-10 | 1 | 7.33 |
| 2024-11 | 0 | 3.8 |
| 2024-12 | 0 | 4.83 |
| 2025-01 | 0 | 5.4 |
| 2025-02 | 0 | 3 |
| 2025-03 | 0 | 4.2 |
| 2025-04 | 0 | 3.83 |
| 2025-05 | 0 | 2.6 |
| 2025-06 | 1 | 4.33 |
| 2025-07 | 0 | 6.25 |
| 2025-08 | 0 | 5.33 |
| 2025-09 | 0 | 3 |
| 2025-10 | 0 | 3.2 |
| 2025-11 | 0 | 3.43 |
| 2025-12 | 0 | 3 |
| 2026-01 | 0 | 3 |
| 2026-02 | 0 | 2.75 |
| 2026-03 | 0 | 2.6 |
| 2026-04 | 0 | 6 |
| 2026-05 | 0 | 3.33 |
| 2026-06 | 0 | 3 |
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-09-26 | Z-0374-2026 | Class I | Open, Classified | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam. | 5,109 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-06-18 | 3014334038-2025-00081 | Injury | Available | exact di |
| 2024-10-04 | 3014334038-2024-00206 | Malfunction | Available | exact di |
| 2023-09-14 | 3014334038-2023-00156 | Malfunction | Available | exact di |
| 2023-08-15 | 3014334038-2023-00137 | Injury | Available | exact di |
| 2023-03-29 | 3014334038-2023-00038 | Malfunction | Available | exact di |
| 2022-11-10 | 3014334038-2022-00255 | Malfunction | Available | exact di |
| 2022-11-09 | 3014334038-2022-00254 | Malfunction | Available | exact di |
| 2022-05-17 | 3014334038-2022-00097 | Injury | Available | exact di |
| 2022-05-17 | 3014334038-2022-00098 | Malfunction | Available | exact di |
Regulatory clearances
Manufacturer compliance record
None in the loaded window.
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