Medtronic Arrive Braided Transseptal Sheath 10f C55¿ recall
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of…
Why was Medtronic Arrive Braided Transseptal Sheath 10f C55¿ 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: C1-08604 Exp. February 20, 2017, C1-08938Exp. May 19, 2017, C1-08986 Exp. June 1, 2017, OR-04488 Exp. June 30, 2017, C1-09756 Exp. February 18, 2018, C1-09757 Exp. February 18, 2018, OR-04633 Exp. March 10, 2018, C1-10118 Exp. April 17, 2018, C1-10119 Exp. April 17, 2018, C1-10147 Exp. April 23, 2018, and C1-12525 Exp. May 17, 2019
- Product
- MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of…
- Recalling firm
- Oscor, Inc.
- Quantity
- 566
- 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)