Home / Recalls / Oscor, Inc. / Z-0816-2017

Z-0816-2017 Class II Terminated

Recalled by Oscor, Inc. — Palm Harbor, FL

FDA device recall Z-0816-2017 was initiated by Oscor, Inc. on Oct 5, 2016 and is designated Class II. Reason for recall: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 1,269.

Recall Details

Product Type: Devices
Report Date: Dec 28, 2016
Initiation Date: Oct 5, 2016
Termination Date: Jul 26, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,269

Product Description

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 for Recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Distribution Pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0816-2017
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Oscor, Inc.

Z-2680-2026 Class I — Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away… (Jun 10, 2026)
Z-2679-2026 Class I — Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away… (Jun 10, 2026)
Z-2678-2026 Class I — Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away… (Jun 10, 2026)
Z-0646-2022 Class II — Destino Twist 14F (also branded as Guidestar 14F) (Dec 22, 2021)
Z-1329-2021 Class II — AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage… (Mar 10, 2021)
Z-0391-2019 Class I — TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight… (Sep 26, 2018)
Z-2733-2017 Class I — ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series… (Mar 31, 2017)
Z-2340-2017 Class I — ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series… (Mar 31, 2017)
Z-0810-2017 Class II — OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to… (Oct 5, 2016)
Z-0811-2017 Class II — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog… (Oct 5, 2016)