FDAClass IIDecember 28, 2016

Medtronic Arrive Braided Transseptal Sheath 10f C90¿ recall

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of…

Why was Medtronic Arrive Braided Transseptal Sheath 10f C90¿ recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of…
Recalling firm
Oscor, Inc.
Quantity
55
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
Recall date
December 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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