Lot #'s: C1-12493 Exp. May 5, 2019

Cardiovascular Devices

2

No

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

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F || C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 || Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Lot #'s: C1-12665 Exp. July 26, 2019

Cardiovascular Devices

2

No

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

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F || C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 || Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Class III

Model: , Affected: Reuseable ATAR multiple lots

Physical Medicine Devices

Model: TME-64S or FGS-0313, Affected: Lots C1-07712 and C1-07113

md

Oscor: TB Series - Bipolar Pacing Leads

Medical electronics / Electromedical devices - electrotherapy

53912 | all

MD: Electrical-only medical device connection cable, single-use

53912A | all

MD: Electrical-only medical device connection cable, single-use