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Terminated

Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.

FDA Recall Z-1981-2014 · Posted 2014-07-03

Recall StatusTerminated
Product CodeDQO
Date Initiated2014-05-27
Date Terminated2015-01-30
Product Quantity8,580 total (US 5714)

Reason for Recall

The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.

Firm Action

Vascular Solutions sent an Urgent Medical Device Removal letter dated May 23, 2014, to all affected consignees.The letter described the problem and the product affected by the recall. Advised consignees to remove affected devices and place them in a secure area. Requested consignees to fill and return the "VSI Account Inventory Form" to VSI's Customer Service Department by email [email protected] or fax 763-656-4251. VSI will replace all returned devices. Customers with questions were advised to contact their local Vascular Solutions Account Manager. For questions regarding this recall call 763-656-4300.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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