Home / Recalls / Oscor, Inc. / Z-0812-2017

Z-0812-2017 Class II Terminated

Recalled by Oscor, Inc. — Palm Harbor, FL

FDA device recall Z-0812-2017 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: 1,729.

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
1,729

Product Description

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 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: C1-08273 Exp. October 8, 2016, C1-08340 Exp. November 11, 2016, C1-08605 Exp. February 20, 2017, C1-08608 Exp. February 20, 2017, C1-08816 Exp. April 8, 2017, C1-08940 Exp. May 19, 2017, C1-09102 Exp. July 21, 2017, C1-09169 Exp. August 21, 2017, C1-09170 Exp. August 21, 2017, C1-09361 Exp. November 3, 2017, C1-09693 Exp. February 10, 2018, C1-09742 Exp. February 16, 2018, C1-09743 Exp. February 16, 2018, C1-09862 Exp. March 5, 2018, C1-09903 Exp. March 15, 2018, C1-10041 Exp. April 5, 2018, C1-10148 Exp. April 23, 2018, C1-10185 Exp. April 27, 2018, C1-10214 Exp. April 29, 2018, C1-10324 Exp. May 11, 2018,C1-11439 Exp. September 16, 2018, C1-11440 Exp. September 16, 2018, C1-11485 Exp. September 22, 2018, C1-11623 Exp. September 29, 2018, C1-11622 Exp. September 29, 2018, C1-11852 Exp. October 16, 2018, OR-04759 Exp. December 22, 2018, and OR-04758 Exp. December 22, 2018

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0812-2017
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

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  • 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-2340-2017 Class I — ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series… (Mar 31, 2017)
  • Z-2733-2017 Class I — ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series… (Mar 31, 2017)
  • Z-0798-2017 Class II — OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is… (Oct 5, 2016)
  • Z-0813-2017 Class II — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog… (Oct 5, 2016)

FDA data resources