Reported Dec 28, 2016 · Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to…
Oscor, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Oscor, Inc. · 3816 Desoto Blvd · Palm Harbor, FL · 34683-1618
Is this the product you have?
- 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.
- Lot codes and dates
Lot #'s: C1-08604 Exp. February 202017C1-08938Exp. May 192017C1-08986 Exp. June 12017OR-04488 Exp. June 302017C1-09756 Exp. February 182018C1-09757 Exp. February 182018OR-04633 Exp. March 102018C1-10118 Exp. April 172018C1-10119 Exp. April 172018C1-10147 Exp. April 232018and C1-12525 Exp. May 172019
- Amount recalled
- 566
This recall covers 30 products
The agency filed one notice per product. You are reading one of them; the other 29 are below.
17 more are in the archive.
Where it was sold
Why it was recalled
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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