Drug recall
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed…
FDA recall event 75785 · Class II · Oscor, Inc.
Key facts
| Event ID | 75785 |
|---|---|
| Recall numbers | Z-0790-2017, Z-0791-2017, Z-0792-2017, Z-0793-2017, Z-0794-2017, Z-0795-2017, Z-0796-2017, Z-0797-2017, Z-0798-2017, Z-0799-2017, Z-0800-2017, Z-0801-2017 and 18 more |
| Recalling firm | Oscor, Inc. |
| Product type | Devices |
| Products | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the…, MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the…, MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left…, MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the…, MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the… and 24 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Initiation date | Oct 5, 2016 |
| Report date | Dec 28, 2016 |
| Termination date | Jul 26, 2019 |
| City | Palm Harbor |
| State | FL |
| Country | United States |
| FEI number | 1035166 |
At a glance
- 10–99 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: