Z-0813-2017 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
- 215
Product Description
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 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: C1-08939 Exp. May 19, 2017, C1-08985 Exp. June 1, 2017, C1-09584 Exp. January 18, 2018, and C1-10120 Exp. April 17, 2018