Oscor, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0817-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Product Classification:

Class II

Date Initiated: October 5, 2016

Date Posted: December 28, 2016

Recall Number: Z-0817-2017

Event ID: 75785

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.

Status: Terminated

Product Quantity: 991

Code Information:

Lot #'s: C1-08341 Exp. November 11, 2016, C1-08607 Exp. February 20, 2017, C1-08803 Exp. April 3, 2017, C1-08941 Exp. May 19, 2017, C1-09173 Exp. August 25, 2017, C1-09394 Exp. November 16, 2017, C1-09531 Exp. December 29, 2017, C1-09718 Exp. February 11, 2018, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 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, and OR-04757 Exp. December 22, 2018 53

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

Voluntary or Mandated:

Voluntary: Firm initiated