FDA Device recall Z-0804-2017
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 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 10F C70¿ S79CM D84CM Catalog # AB101077 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-0804-2017 |
| 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 10F C70¿ S79CM D84CM Catalog # AB101077 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: C1-08611 Exp. February 20, 2017, C1-09397 Exp. November 17, 2017, C1-09408 Exp. November 25, 2017, C1-09408…Lot #'s: C1-08611 Exp. February 20, 2017, C1-09397 Exp. November 17, 2017, C1-09408 Exp. November 25, 2017, C1-09408 Exp. November 25, 2017, C1-09861 Exp. March 5, 2018, C1-09858 Exp. March 5, 2018, C1-09861 Exp. March 5, 2018, C1-10901 Exp. July 19, 2018, C1-11205 Exp. August 24, 2018, C1-11205 Exp. August 24, 2018, C1-12250 Exp. January 4, 2019, C1-08611 Exp. February 20, 2017, and C1-11205 Exp. August 24, 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-0804-2017%22
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