Home / Recalls / Vascular Solutions, Inc. / Z-0868-2013

Z-0868-2013 Class II Terminated

Recalled by Vascular Solutions, Inc. — Maple Grove, MN

Recall Details

Product Type
Devices
Report Date
February 27, 2013
Initiation Date
January 29, 2013
Termination Date
June 25, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4731

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.

Distribution Pattern

Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.

Code Information

559450, 551750, 552370, 552761, 552840, 552954, 553267, 553647, 553931, 554269, 554270, 554413. 555958, 557192, 557824, 558222, 558894, 559827, 560215, 551751, 552371, 552841, 553090, 553218, 553434, 553529, 554029, 554268, 554271, 555759, 555953, 557251, 559570, 559981, 560253, 560079, 560080, 554123, 556182, 558905, 560114, 554210, 555991, 556842, 557253, 554209, 555223, 555992, 556536, 556747, 557124, 558327, 558991, 560115, 561206, 554208, 555490, 555993, 556674, 556843, 558018, 558798, 559707, 560433, 561207, 554040, 555007, 555224, 555358, 558542, 560434, 561459, 554122, 555008, 555225, 555994, 558992, 561208, 560221, 560222, 560223, 560995, 560996.

Other recalls by Vascular Solutions, Inc.

  • Z-0112-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-0110-2021 Class I — Langston Dual Lumen Catheter (August 31, 2020)
  • Z-0111-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-0113-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-1747-2020 Class I — Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in (March 16, 2020)
  • Z-2249-2018 Class II — Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (May 4, 2018)
  • Z-2224-2017 Class I — Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Ca (April 25, 2017)
  • Z-2180-2017 Class II — Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. (April 12, 2017)
  • Z-1250-2017 Class II — GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Pr (January 12, 2017)
  • Z-0053-2017 Class I — Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. (September 16, 2016)