FDAFDA · Food and drugs·Recall number Z-0817-2017
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Published December 28, 2016 · Recall initiated: October 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Oscor, Inc.
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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