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.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-06-07 | Z-2331-2024 | Class II | Open, Classified | Potential sheath damage that could lead to tissue damage and/or track hemorrhage.Distribution: Domestic: NY, OH, & DC. | 14 units | clearance family |
Regulatory clearances
- 510(k)K250752Substantially equivalent (SESE) · 2025-04-09clearance family
- 510(k)K232618Substantially equivalent (SESE) · 2023-10-27clearance family
Predicate lineage
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 |
|---|---|---|---|---|
| 2025-09-17 | NAI | No action indicated | Integra LifeSciences Corporation | 0 |
| 2025-09-17 | NAI | No action indicated | Integra LifeSciences Corporation | 0 |
| 2025-06-06 | NAI | No action indicated | Integra LifeSciences Corporation | 0 |
| 2025-06-06 | NAI | No action indicated | Integra LifeSciences Corporation | 0 |
| 2025-02-12 | NAI | No action indicated | Surgical Innovation Associates Inc | 0 |
| 2024-12-19 | WL | Warning Letter | Integra LifeSciences Corporation | — |
| 2024-12-19 | WL | Warning Letter | Integra LifeSciences Corporation | — |
| 2024-08-22 | OAI | Official action indicated | Integra LifeSciences Corp. (NeuroSciences) | 0 |
| 2024-08-22 | OAI | Official action indicated | Integra LifeSciences Corporation | 0 |
| 2024-08-22 | OAI | Official action indicated | Integra LifeSciences Corporation | 0 |
| 2024-06-05 | OAI | Official action indicated | Integra LifeSciences Corporation | 7 |
| 2024-06-05 | OAI | Official action indicated | Integra LifeSciences Corporation | 7 |
| 2023-07-17 | WL | Warning Letter | TEI Biosciences, Inc. | — |
| 2023-05-17 | OAI | Official action indicated | TEI Biosciences, Inc. | 7 |
| 2023-03-24 | NAI | No action indicated | Integra Neurosciences | 0 |
| 2021-11-12 | VAI | Voluntary action indicated | TEI Biosciences, Inc. | 6 |
| 2021-07-15 | VAI | Voluntary action indicated | Surgical Innovation Associates Inc | 0 |
| 2019-08-23 | VAI | Voluntary action indicated | Integra Neurosciences | 5 |
| 2019-08-23 | NAI | No action indicated | Integra LifeSciences Corp. (NeuroSciences) | 0 |
| 2019-05-16 | NAI | No action indicated | REBOUND THERAPEUTICS, CORPORATION | 0 |
| 2019-03-06 | WL | Warning Letter | TEI Biosciences, Inc. | — |
| 2018-11-02 | OAI | Official action indicated | TEI Biosciences, Inc. | 0 |
| 2018-07-02 | VAI | Voluntary action indicated | Integra LifeSciences Corporation | 4 |
| 2018-07-02 | VAI | Voluntary action indicated | Integra LifeSciences Corporation | 4 |
| 2015-05-29 | WL | Warning Letter | TEI Biosciences, Inc. | — |
| 2013-04-26 | WL | Warning Letter | ACell, Inc | — |
| 2013-02-13 | WL | Warning Letter | Integra Neurosciences | — |
| 2011-12-21 | WL | Warning Letter | Integra LifeSciences Corporation | — |
| 2011-12-21 | WL | Warning Letter | Integra LifeSciences Corporation | — |
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