Oscor, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0803-2017)

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 C55¿ S79CM D84CM Catalog # AB101076 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-0803-2017

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: 74

Code Information:

Lot #'s: C1-12572 Exp. June 17, 2019, C1-10896 Exp. July 16, 2018, C1-10896 Exp. July 16, 2018, C1-12139 Exp. November 24, 2018, C1-12572 Exp. June 17, 2019, C1-09133 Exp. August 3, 2017, C1-09133 Exp. August 3, 2017, C1-09943 Exp. March 19, 2018, OR-04641 Exp. March 26, 2018, and C1-10896 Exp. July 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