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.
Reported: July 9, 2014 Initiated: May 27, 2014 #Z-1981-2014
Product Description
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.
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.
Details
- Recalling Firm
- Vascular Solutions, Inc.
- Units Affected
- 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.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Vascular Solutions, Inc.. Units affected: 8,580 total (US 5714).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2014. Severity: Critical. Recall number: Z-1981-2014.
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