Z-1655-2012

Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions...

Name: Z-1655-2012 Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions...
Creator: Vascular Solutions, Inc.
Published: 2012-01-17
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2012-01-17 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369... on 2012-01-17. The reason FDA records is "Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on...". 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-1655-2012
Status: Terminated
Initiated: 2012-01-17
Posted: 2012-05-24
Terminated: 2012-07-19
Recalling firm: Vascular Solutions LLC
Product: Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices.
Product code: DQY Catheter, Percutaneous
Reason for recall: Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Vascular Solutions sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product , immediately remove the product and place the product in a secure area. Additionally, customers were asked to complete and return a Field Action Customer Inventory Form to the Customer Service Department via fax at 763-656-4251 or e-mail at [email protected]. Customers may contact their local sales representative for questions concerning this recall.
Quantity in commerce: 330
Distribution: Nationwide Distribution including the states of AL, AZ, AR, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LAM ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, WV, and WI.
Product codes and lots: 555038

Product code DQY

K112082Class IIGuideliner V2 CatheterVascular Solutions, Inc. / cleared 2011-12-01

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)