Vascular Solutions, Inc. Recalls

All product recalls associated with Vascular Solutions, Inc..

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Recall Summary

Total Recalls

12

Past Year

0

Class I (Serious)

0

Most Recent

Aug 2020

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–12 of 12 recalls

Vascular Solutions, Inc.: Langston Dual Lumen Catheter

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

FDAAug 31, 2020AL, AK, AZ +49 more• Vascular Solutions, Inc.

Vascular Solutions, Inc.: Langston Dual Lumen Catheter 6F Model 5540. For delivery...

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

FDAMar 16, 2020Nationwide• Vascular Solutions, Inc.

Vascular Solutions, Inc.: Vascular Solutions Pronto-Short Extraction Catheter. Mode...

It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The guidewire is sterilized separately and was realized to have an expiration date of October 31, 2009.

FDA

Nov 20, 2009

Nationwide

• Vascular Solutions, Inc.

Vascular Solutions, Inc.: Twin-Pass Dual Access Catheter , REF 5200, sterilized wit...

Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging

FDAJul 2, 2009AL, AK, AZ +48 more• Vascular Solutions, Inc.

Guidant Endovascular Solutions, Inc.: Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System...

Laceration Risk

Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action.

FDAMar 22, 2006Nationwide• Guidant Endovascular Solutions, Inc.

Guidant Endovascular Solutions, Inc.: ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 c...

Laceration Risk

Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action.

FDAMar 22, 2006Nationwide• Guidant Endovascular Solutions, Inc.

Vascular Solutions, Inc.: D-Stat Hemostat Band, model number 3500. Sterile, latex ...

A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.

FDASep 9, 2005AL, AZ, AR +37 more• Vascular Solutions, Inc.

Vascular Solutions, Inc.: D-Stat Dry Hemostatic Bandage, model number 3000. Steril...

A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.

FDASep 9, 2005AL, AZ, AR +37 more• Vascular Solutions, Inc.

Vascular Solutions, Inc.: D-Stat 2 Dry Hemostatic Bandage, model number 3010. Ster...

A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch is not in question.

FDASep 9, 2005AL, AZ, AR +37 more• Vascular Solutions, Inc.

Guidant Endovascular Solutions, Inc.: Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter.

FDAAug 8, 2005Nationwide• Guidant Endovascular Solutions, Inc.

Vascular Solutions, Inc.: The Pronto Extraction Catheter is indicated for the remov...

The marker band in guidewire lumen could move from the manufactured location during clinical use.

FDAMay 12, 2004Nationwide• Vascular Solutions, Inc.

Vascular Solutions, Inc: Vari-Lase Endovenous Laser Procedural Kit, Model 7000

An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement.

FDAOct 9, 2003Nationwide• Vascular Solutions, Inc

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Vascular Solutions, Inc. Recalls

Recall Summary

Vascular Solutions, Inc.: Langston Dual Lumen Catheter

Vascular Solutions, Inc.: Langston Dual Lumen Catheter 6F Model 5540. For delivery...

Vascular Solutions, Inc.: Vascular Solutions Pronto-Short Extraction Catheter. Mode...

Vascular Solutions, Inc.: Twin-Pass Dual Access Catheter , REF 5200, sterilized wit...

Guidant Endovascular Solutions, Inc.: Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System...

Guidant Endovascular Solutions, Inc.: ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 c...

Vascular Solutions, Inc.: D-Stat Hemostat Band, model number 3500. Sterile, latex ...

Vascular Solutions, Inc.: D-Stat Dry Hemostatic Bandage, model number 3000. Steril...

Vascular Solutions, Inc.: D-Stat 2 Dry Hemostatic Bandage, model number 3010. Ster...

Guidant Endovascular Solutions, Inc.: Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

Vascular Solutions, Inc.: The Pronto Extraction Catheter is indicated for the remov...

Vascular Solutions, Inc: Vari-Lase Endovenous Laser Procedural Kit, Model 7000