Maple Grove, MN, United States
Vascular Solutions, Inc. recalls
3 recalls recorded since 2018, most recently on 31 August 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)2
Terminated Class I Medical devices
- Recall started
- 31 August 2020
- Terminated
- 18 June 2024
- Reason
- The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- Distribution
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0111-2021, Z-0110-2021, Z-0113-2021, Z-0112-2021
- Langston Dual Lumen Catheter.
- Langston Dual Lumen Catheter
- Langston Dual Lumen Catheter.
- Langston Dual Lumen Catheter.
Terminated Class I Medical devices
- Recall started
- 16 March 2020
- Terminated
- 18 June 2024
- Reason
- The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- Distribution
- Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1747-2020
- Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Terminated Class II Medical devices
- Recall started
- 4 May 2018
- Terminated
- 5 October 2020
- Reason
- The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2249-2018
- Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drai
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.