Recall Z-1981-2014 ยท DQO Catheter, Intravascular, Diagnostic
Vascular Solutions, Inc.
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.
| Date | Jul 3, 2014 (initiated May 27, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| 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 customerservice@vasc.com 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 reca |
| Quantity | 8,580 total (US 5714) |
| Distribution | Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051395 | LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER Vascular Solutions, Inc., Jun 24, 2005 |