Vascular Solutions Recalls Twin-Pass Catheters Due to Manufacturing Material
Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the tip or in the distal lumen.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for excess material in the vasculature, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vascular Solutions, Inc. is recalling the Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. These are dual lumen catheters designed for use in the coronary and/or peripheral vasculature. The recall involves 11,670 units distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations.
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 source text does not specify reported injuries or illnesses associated with this defect.
Healthcare providers and facilities should check their inventory for the affected models and lot numbers listed in the official recall notice. Users should stop using the affected devices and contact Vascular Solutions for further instructions.
The recalled product
- Product
- Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. 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
- Manufacturer
- Vascular Solutions, Inc.
- Category
- Medical Device — Catheter
- 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 (20)
- Model 5200
- Lot numbers: 575653
- 577278
- 577761
- 578419
- 578996
- 579472
- 579787
- 580186
- 580612
- 581252
- 582138
- 582579
- 582580
- 583785
- 584155
- 584156
- 584812
- 585176
- 585784
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
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