Reported Dec 28, 2016 · Terminated

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to…

Oscor, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Oscor, Inc. · 3816 Desoto Blvd · Palm Harbor, FL · 34683-1618

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Lot codes and dates: Lot #'s: C1-08310 Exp. October 29
2016
C1-08364 Exp. November 21
2016
C1-08606 Exp. February 20
2017
C1-08611 Exp. February 20
2017
C1-08802 Exp. April 3
2017
C1-08857 Exp. April 22
2017
C1-09091 Exp. July 10
2017
C1-09090 Exp. July 10
2017
C1-09859 Exp. March 5
2018
C1-09860 Exp. March 5
2018
C1-09880 Exp. March 11
2018
C1-09921 Exp. March 16
2018
C1-10039 Exp. April 5
2018
C1-10141 Exp. April 22
2018
C1-10141 Exp. April 22
2018
C1-10146 Exp. April 23
2018
C1-10242 Exp. May 4
2018
C1-10240 Exp. May 4
2018
C1-10241 Exp. May 4
2018
C1-11206 Exp. August 24
2018
C1-11206 Exp. August 24
2018
C1-11572 Exp. September 25
2018
C1-11572 Exp. September 25
2018
C1-11850 Exp. October 16
2018
and C1-11849 Exp. October 16
2018
Amount recalled: 1,269

The agency filed one notice per product. You are reading one of them; the other 29 are below.

17 more are in the archive.

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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