FDA Device recall Z-0797-2017
OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the hear…
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the hear… by Oscor, citing complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0797-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-05 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Oscor |
| Distribution | CA, FL, MD, MO, NC, NJ, PR, TX |
Product
OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Reason
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Identifiers
| code_info | Lot #'s: C1-09372 Exp. November 5, 2017, C1-10142 Exp. April 22, 2018 and OR-04728 Exp. October 21, 2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0797-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.