Z-0811-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- October 5, 2016
- Termination Date
- July 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 566
Product Description
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 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.
Reason for Recall
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Distribution Pattern
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
Code Information
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