Drug recall
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers…
FDA recall event 76249 · Class II · Medtronic Neurosurgery
Key facts
| Event ID | 76249 |
|---|---|
| Recall numbers | Z-1121-2017 |
| Recalling firm | Medtronic Neurosurgery |
| Product type | Devices |
| Products | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level… |
| Initiation date | Jan 17, 2017 |
| Report date | Feb 8, 2017 |
| Termination date | Jun 2, 2017 |
| City | Goleta |
| State | CA |
| Country | United States |
| FEI number | 2021898 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: