FDA Device recall Z-0800-2017
OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 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 C55¿ S61CM D66CM Catalog # AB101072 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-0800-2017 |
| 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 C55¿ S61CM D66CM Catalog # AB101072 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: C1-09396 Exp. November 17, 2017, C1-09396 Exp. November 17, 2017, C1-08804 Exp. April 1, 2017, and C1-09396 Exp. November 17, 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Oscor
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and acces…
FDA Device · Class I · 2026-07-22 · Oscor - Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
FDA Device · Class I · 2026-07-22 · Oscor - Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and…
FDA Device · Class I · 2026-07-22 · Oscor - Destino Twist 14F (also branded as Guidestar 14F)
FDA Device · Class II · 2022-02-23 · Oscor - AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads a…
FDA Device · Class II · 2021-04-07 · Oscor
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0800-2017%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.