Oscor, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0814-2017)

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 C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 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-0814-2017

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: 186

Code Information:

Lot #'s: C1-08466 Exp. December 19, 2016, C1-09857 Exp. March 5, 2018, C1-10215 Exp. April 29, 2018, and C1-11438 Exp. September 16, 2018

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