Z-2608-2010

Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore...

Name: Z-2608-2010 Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore...
Creator: Vascular Solutions, Inc.
Published: 2010-09-02
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2010-09-02 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, - 0.038"... on 2010-09-02. The reason FDA records is "Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430...". 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-2608-2010
Status: Terminated
Initiated: 2010-09-02
Posted: 2010-09-28
Terminated: 2012-04-24
Recalling firm: Vascular Solutions LLC
Product: Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, - 0.038" recom guidewire, 1000 psi pressure limit. Usage: 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 interventricular pressure gradients.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. Recently, it was reported that pouches containing Langston Pigtail catheter (Model 5540) were missing a seal, posing a risk of product contamination. It is possib
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent on 9/2/10, a Vascular Solutions "Urgent Medical Device Field Action" letter dated September 1, 2010. The letter was addressed to Cath Lab Manager. The letter descried the product and the problem. Provided instructions to examine pouches of opened boxes to see if they have not been sealed. If unsealed, they recommended to remove pouches from the current inventory. For unopened boxes they recommended to remove the boxes from the inventory. Requested consignees to complete the Field Action Customer Inventory Form included with the letter. For any questions, please contact the firm at 763-656-6032.
Quantity in commerce: 1,128 boxes ( 5pk)
Distribution: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS,MO, NE, NY,NH, NJ, NM, NY,NC, OH, OK, OR, A, PR, SC, TN, TX, UT, VA, WA, WV, WI, and WY. SINGAPORE, MEXICO, CANADA, SPAIN, AUSTRIA, GERMANY, ITALY, ENGLAND, and SWITZERLAND.
Product codes and lots: Lot 548110, 548227, 548364, 548430, 548554, and 548723.

Product code DQO

K051395Class IILangston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. / cleared 2005-06-24

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)