Recall Z-1981-2014— Vascular Solutions, Inc.
Class I · Terminated
Class I FDA medical device recall by Vascular Solutions, Inc., initiated 2014-05-27, terminated 2015-01-30. It names one FDA 510(k) clearance: K051395. Product: 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: 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..
- Recalling firm
- Vascular Solutions, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-05-27
- Terminated
- 2015-01-30
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.