Recall Z-0868-2013— Vascular Solutions, Inc.

Name: FDA recall Z-0868-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-29

Class II · Terminated

Class II FDA medical device recall by Vascular Solutions, Inc., initiated 2013-01-29, terminated 2013-06-25. It names one FDA 510(k) clearance: K101659. Product: Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents. Reason: Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing..

Recalling firm: Vascular Solutions, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-29
Terminated: 2013-06-25
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K101659 — SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301Vascular Solutions, Inc.·cleared 2010-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents

Reason for recall

Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.