Class II — Oscor, Inc.
| Recalling firm | OSCOR INC. |
|---|---|
| Registered facility | OSCOR INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. |
| Product | OSCOR ADELANTE BREEZEWAY 8F C70® S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. |
| Quantity | 87 |
| Distribution | Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM |
| Initiated | 2016-10-05 |
| Classified | 2016-12-19 |
| Terminated | 2019-07-26 |
| Recall number | Z-0791-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Oscor, Inc. (Z-0791-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75785/
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