FDA Device recall Z-0816-2017

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction…

FDA Device
Class II
terminated
Published 2016-12-28

On 2016-12-28 the FDA classified a Class II recall of MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction… 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-0816-2017
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

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 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: C1-08310 Exp. October 29, 2016, C1-08364 Exp. November 21, 2016, C1-08606 Exp. February 20, 2017, C1-08611… Lot #'s: C1-08310 Exp. October 29, 2016, C1-08364 Exp. November 21, 2016, C1-08606 Exp. February 20, 2017, C1-08611 Exp. February 20, 2017, C1-08802 Exp. April 3, 2017, C1-08857 Exp. April 22, 2017, C1-09091 Exp. July 10, 2017, C1-09090 Exp. July 10, 2017, C1-09859 Exp. March 5, 2018, C1-09860 Exp. March 5, 2018, C1-09880 Exp. March 11, 2018, C1-09921 Exp. March 16, 2018, C1-10039 Exp. April 5, 2018, C1-10141 Exp. April 22, 2018, C1-10141 Exp. April 22, 2018, C1-10146 Exp. April 23, 2018, C1-10242 Exp. May 4, 2018, C1-10240 Exp. May 4, 2018, C1-10241 Exp. May 4, 2018, C1-11206 Exp. August 24, 2018, C1-11206 Exp. August 24, 2018, C1-11572 Exp. September 25, 2018, C1-11572 Exp. September 25, 2018, C1-11850 Exp. October 16, 2018, and C1-11849 Exp. October 16, 2018

code_info

Lot #'s: C1-08310 Exp. October 29, 2016, C1-08364 Exp. November 21, 2016, C1-08606 Exp. February 20, 2017, C1-08611…

Lot #'s: C1-08310 Exp. October 29, 2016, C1-08364 Exp. November 21, 2016, C1-08606 Exp. February 20, 2017, C1-08611 Exp. February 20, 2017, C1-08802 Exp. April 3, 2017, C1-08857 Exp. April 22, 2017, C1-09091 Exp. July 10, 2017, C1-09090 Exp. July 10, 2017, C1-09859 Exp. March 5, 2018, C1-09860 Exp. March 5, 2018, C1-09880 Exp. March 11, 2018, C1-09921 Exp. March 16, 2018, C1-10039 Exp. April 5, 2018, C1-10141 Exp. April 22, 2018, C1-10141 Exp. April 22, 2018, C1-10146 Exp. April 23, 2018, C1-10242 Exp. May 4, 2018, C1-10240 Exp. May 4, 2018, C1-10241 Exp. May 4, 2018, C1-11206 Exp. August 24, 2018, C1-11206 Exp. August 24, 2018, C1-11572 Exp. September 25, 2018, C1-11572 Exp. September 25, 2018, C1-11850 Exp. October 16, 2018, and C1-11849 Exp. October 16, 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-0816-2017%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.