Oscor, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0809-2017)

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 10F STRAIGHT S61CM D66CM Catalog # AB10218 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-0809-2017

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: 20

Code Information:

Lot #'s: C1-11201 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, and C1-11873 Exp. October 21, 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