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Recall Observatory FDA recall evidence

Device product

Langston Dual Lumen Catheter.

Z-0112-2021

August 31, 2020

Class I

Product summary

Firm
Vascular Solutions, Inc.
Event
Event 86433
Status
Terminated
Classification
Class I
Quantity
1,745 units
Official record key
device-enforcement:Z-0112-2021

Official wording

Reason: The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Code information: Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, 668503.

Distribution pattern: Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The inner lumen of the Langston catheter may separate from the hub during pressure injection.