Drug recall
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced…
FDA recall event 85649 · Class I · Medtronic Vascular Galway DBA Medtronic Ireland
Key facts
| Event ID | 85649 |
|---|---|
| Recall numbers | Z-2039-2020 |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland |
| Product type | Devices |
| Products | Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) |
| Initiation date | May 12, 2020 |
| Report date | Jun 3, 2020 |
| Termination date | Mar 10, 2022 |
| City | Galway |
| Country | Ireland |
| FEI number | 3002806434 |
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: