Z-0803-2017Class II

OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of...

Name: Z-0803-2017 OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of...
Creator: Oscor, Inc.
Published: 2016-10-05
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2016-10-05 / Terminated / root cause: manufacturing process

FDA source

Oscor, Inc. began a recall of OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including... on 2016-10-05. FDA classified it as Class II and gives the reason as "Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0803-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-12-19
Terminated: 2019-07-26
Recalling firm: Oscor Inc.
Product: 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 code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Oscor sent two(2) Product Recall notifications: -HOSPITALS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Review, complete, sign and return the enclosed Acknowledgement Form attached in the letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email [email protected] Hours of operations: Monday to Friday from 8:30AM to 5:30PM Eastern Time. - DISTRIBUTORS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Please pull a list of the hospitals (end user) impacted by the affected lots and retrieve inventory for replacement, if available. Review, complete, sign and return the enclosed Acknowledgement Form (Exhibit A) attached in this letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email [email protected] Hours of operation: Monday to Friday from 8:30AM to 5:30PM Eastern Standard Time.
Quantity in commerce: 74
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0803-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0790-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0791-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0792-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0793-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0794-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0795-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0796-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0797-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0798-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0799-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0800-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0801-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0802-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0803-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0804-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0805-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0806-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0807-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0808-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0809-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0810-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0811-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0812-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0813-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0814-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0815-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0816-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0817-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0818-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19
Z-0819-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-19

Product code DYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)