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Oscor, Inc. recalls MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facil
Recalled December 28, 2016 · FDA recall Z-0817-2017 · Oscor
Hazard
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. · FDA Class II
Units
991
Sold at
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
Description
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Manufacturer(s)
Oscor, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →