Z-1712-2009

Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic...

Name: Z-1712-2009 Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic...
Creator: Vascular Solutions, Inc.
Published: 2009-07-02
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2009-07-02 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore... on 2009-07-02. The reason FDA records is "Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic...". 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-1712-2009
Status: Terminated
Initiated: 2009-07-02
Posted: 2009-08-21
Terminated: 2012-04-03
Recalling firm: Vascular Solutions LLC
Product: Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
Product code: DQY Catheter, Percutaneous
Reason for recall: Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Vascular Solutions, Inc. issued an "Urgent: Medical Device Recall - Lot Specific" notice dated July 6, 2009. The letter described the problem and product involved and asked Consignees to immediately check their Twin-Pass catheter inventory, remove any affected units and complete the Product Recall Inventory Form and return to Customer Service Department. For further questions, contact Vascular Solutions, Inc. at 1-763-656-4300.
Quantity in commerce: 5885
Distribution: Worldwide Distribution -- Including Puerto Rico and states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and DC and countries of CANADA, SPAIN, GREECE, IRELAND, NORWAY, SWITZERLAND, ENGLAND, TURKEY, ISRAEL, GERMANY, AUSTRIA, TAIWAN, FINLAND, SWEDEN, FRANCE, IRELAND and PORTUGAL.
Product codes and lots: Lot Numbers: 540787, 540909, 541079, 541304, 541342, 541881, 541992, 542111, 542253, 542302, 542693, 542875, 542962, 542994, 543173, 543304, 543508, 543590, 543591, 543698, 543775, 543922, 544188, 544315, 544597 and 544831.

Product code DQY

K060327Class IIVascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. / cleared 2006-04-12

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)