FDA Device recall Z-0794-2017

OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart…

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 C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart… 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-0794-2017
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 C55¿ S79CM D84CM Catalog # AB081044 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: C1-12152 Exp. November 30, 2018, C1-09518 Exp. December 21, 2017, C1-09748 Exp. February 16, 2018, C1-09899 E… Lot #'s: C1-12152 Exp. November 30, 2018, C1-09518 Exp. December 21, 2017, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 2018

code_info

Lot #'s: C1-12152 Exp. November 30, 2018, C1-09518 Exp. December 21, 2017, C1-09748 Exp. February 16, 2018, C1-09899 E…

Lot #'s: C1-12152 Exp. November 30, 2018, C1-09518 Exp. December 21, 2017, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 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-0794-2017%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.