Z-2770-2011

Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular...

Name: Z-2770-2011 Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular...
Creator: Vascular Solutions, Inc.
Published: 2011-06-09
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2011-06-09 / Terminated / root cause: packaging

FDA source

Vascular Solutions, Inc. began a recall of Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN... on 2011-06-09. The reason FDA records is "Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2770-2011
Status: Terminated
Initiated: 2011-06-09
Posted: 2011-07-11
Terminated: 2012-04-05
Recalling firm: Vascular Solutions LLC
Product: Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it was reported that pouches containing Langston catheters (Model 5515) were missing a seal, posing a risk of product contamination. It is possible that a compromised sterile barrier
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Vascular Solutions, Inc. sent an "URGENT MEDICAL DEVICE FIELD ACTION- LOT SPECIFIC" letter dated June 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructed customers to check their inventory for the affected product and provided information on how to examine the product. Customers are to complete and return a Field Action Customer Inventory Form via fax at 763-656-4250 or e-mail at www.vascularsolutions.com. VSI Customer Service will contact customers to set up return shipment of affected product. All affected product will be replaced upon receipt of the shipped product. Customers should contact their local Sales Representative for questions concerning this recall.
Quantity in commerce: 23 (5 pack) boxes
Distribution: Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, MA, MI, MO, NM, NC, OK, and WA and the countries of Austria and Canada.
Product codes and lots: 548264

Product code DQO

K061565Class IILangston Dual Lumen CatheterVascular Solutions, Inc. / cleared 2006-08-02

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)