Reported Dec 28, 2016 · Terminated

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 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¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 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: C1-08273 Exp. October 8
2016
C1-08340 Exp. November 11
2016
C1-08605 Exp. February 20
2017
C1-08608 Exp. February 20
2017
C1-08816 Exp. April 8
2017
C1-08940 Exp. May 19
2017
C1-09102 Exp. July 21
2017
C1-09169 Exp. August 21
2017
C1-09170 Exp. August 21
2017
C1-09361 Exp. November 3
2017
C1-09693 Exp. February 10
2018
C1-09742 Exp. February 16
2018
C1-09743 Exp. February 16
2018
C1-09862 Exp. March 5
2018
C1-09903 Exp. March 15
2018
C1-10041 Exp. April 5
2018
C1-10148 Exp. April 23
2018
C1-10185 Exp. April 27
2018
C1-10214 Exp. April 29
2018
C1-10324 Exp. May 11
2018
C1-11439 Exp. September 16
2018
C1-11440 Exp. September 16
2018
C1-11485 Exp. September 22
2018
C1-11623 Exp. September 29
2018
C1-11622 Exp. September 29
2018
C1-11852 Exp. October 16
2018
OR-04759 Exp. December 22
2018
and OR-04758 Exp. December 22
2018
Amount recalled: 1,729

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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