Oscor, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0791-2017)

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:

OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 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-0791-2017

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: 87

Code Information:

Lot #'s: C1-12312 Exp. January 18, 2019, OR-04686 Exp. July 16, 2018, Exp. April 21, 2015, OR-04655 Exp. April 20, 2018, C1-10985 Exp. July 28, 2018, OR-04686 Exp. July 16, 2018, C1-12312 Exp. January 18, 2019, C1-12312 Exp. January 18, 2019, and OR-04655 Exp. April 20, 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