Drug recall
Visualase Cooled Laser Applicator System (VCLAS) 9735560.4MM CORE FIBER 10MM TIP product. Used to necrotize…
FDA recall event 91041 · Class II · Medtronic Navigation, Inc.
Key facts
| Event ID | 91041 |
|---|---|
| Recall numbers | Z-0244-2023 |
| Recalling firm | Medtronic Navigation, Inc. |
| Product type | Devices |
| Products | Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a defect in the outer pouch sterile seal |
| Initiation date | Oct 14, 2022 |
| Report date | Nov 23, 2022 |
| City | Louisville |
| State | CO |
| Country | United States |
| FEI number | 1000517638 |
At a glance
- 1–9 Products in this recall
- 10–99 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: