Medtronic Arrive Braided Transseptal Sheath 10f C90¿ recall
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 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: C1-08341 Exp. November 11, 2016, C1-08607 Exp. February 20, 2017, C1-08803 Exp. April 3, 2017, C1-08941 Exp. May 19, 2017, C1-09173 Exp. August 25, 2017, C1-09394 Exp. November 16, 2017, C1-09531 Exp. December 29, 2017, C1-09718 Exp. February 11, 2018, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 2018 53
- Product
- MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of…
- Recalling firm
- Oscor, Inc.
- Quantity
- 991
- 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)