Z-0868-2013Class II

Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300...

Name: Z-0868-2013 Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300...
Creator: Vascular Solutions, Inc.
Published: 2013-01-29
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2013-01-29 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and... on 2013-01-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0868-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-29
Posted: 2013-02-20
Terminated: 2013-06-25
Recalling firm: Vascular Solutions LLC
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
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Vascular Solutions sent an "Urgent Medical device Recall" letter dated January 28, 29013 to all affected customers. The letter identified the affected product, described the problem and actions to be taken. The letter advised customers to remove the product from their inventory and to complete and return the VSI Account Inventory Form. For questions contact your local Sales Representative.
Quantity in commerce: 4731
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0868-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0868-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20

Product code DQY

K101659Class IISupercross Microcatheter (130 Cm), Supercross Microcatheter (150 Cm) Model 5300, 5301Vascular Solutions, Inc. / cleared 2010-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)