Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- United StatesOptaBlate07613327601169
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.
6 linked reportsMalfunction 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2025-10 | 1 | — |
| 2026-02 | 1 | — |
| 2026-03 | 2 | — |
| 2026-04 | 1 | — |
| 2026-05 | 1 | — |
Failure-mode summaryAI-generated
6 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-28 | 3015967359-2026-00412 | Malfunction | Available | exact di |
| 2026-04-14 | 3015967359-2026-00230 | Malfunction | Available | exact di |
| 2026-03-05 | 3015967359-2026-00147 | Malfunction | Available | exact di |
| 2026-03-05 | 3015967359-2026-00148 | Malfunction | Available | exact di |
| 2026-02-06 | 3015967359-2026-00074 | Malfunction | Available | exact di |
| 2025-10-29 | 3015967359-2025-01570 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2011-01-05 | NAI | No action indicated | Stryker Instruments | 0 |
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