Vascular Solutions Recalls Twin-Pass RX Dual Access Catheters Due to Manufacturing Defect
Vascular Solutions is recalling Twin-Pass RX Dual Access Catheters because excess manufacturing material may remain at the tip or within the distal lumen.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen."
Plain-English summary
Vascular Solutions, Inc. is recalling the Twin-Pass RX Dual Access Catheter, model 5210, lot number 577762. The recall involves 11,670 units that were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international markets.
The recall is being conducted because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature.
Healthcare providers and facilities should stop using the affected devices and contact Vascular Solutions for further instructions regarding the recall.
The recalled product
- Product
- Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230)…
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 11,670
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model 5210
- Lot number: 577762
Distribution
Part of a larger recall action
This product is one of 3 recalled by Vascular Solutions, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Vascular Solutions, Inc.
See all →- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
FDA (Devices) · 2020-10-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
FDA (Devices) · 2020-05-06
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- HighVascular Solutions Recalls SuperCross Microcatheters Due to Surface Contamination
FDA (Devices) · 2013-02-27
- SevereVascular Solutions Recalls Venture Catheters Due to Material Detachment Risk
FDA (Devices) · 2017-06-28
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk
FDA (Devices) · 2014-07-09
- SevereVascular Solutions Recalls Langston Dual Lumen Catheters Due to Lumen Separation
FDA (Devices) · 2020-10-28
- HighVascular Solutions Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins
FDA (Devices) · 2018-06-27
- HighVascular Solutions Recalls Guardian II Hemostasis Valves Due to Missing Seals
FDA (Devices) · 2012-09-26