Medtronic Arrive Braided Transseptal Sheath 10f C70¿ recall
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of…
Why was Medtronic Arrive Braided Transseptal Sheath 10f C70¿ 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: C1-08310 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
- Product
- MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of…
- Recalling firm
- Oscor, Inc.
- Quantity
- 1,269
- 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)