Galt Medical Recalls Valved Tearaway Introducer Sets Due to Embolic Risk
Galt Medical Corporation is recalling 11,155 Valved Tearaway Introducer Sets because the adhesive may dislodge, posing an embolic risk to patients.
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 is classified as FDA Class II, and the hazard involves a risk of harm (embolic risk) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Galt Medical Corporation is recalling 11,155 units of the Galt Valved Tearaway Introducer Set (GALT VTI). These sterile, prescription-only medical devices are used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. The affected units were distributed worldwide, including in the United States, Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
The recall was initiated because the adhesive used in the product could dislodge when objects are inserted through the valve. This potential dislodgement could pose an embolic risk to the patient. The recall covers specific catalog numbers including NT-104-06, INT-104-07, and various VTI-002 and VTI-003 series units.
Healthcare providers and facilities should stop using the affected products and contact Galt Medical Corporation for further instructions on the recall process.
The recalled product
- Product
- GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Introducer Sets
- Affected units
- 11,155
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)
- Catalog Numbers: NT-104-06
- INT-104-07
- INT-104-08
- INT-104-09
- INT-104-10
- INT-104-11
- INT-104-12
- INT-104-17
- INT-104-18
- INT-104-19
- INT-104-20
- INT-104-21
- INT-104-22
- INT-104-23
- INT-108-06
- INT-108-07
- INT-108-09
- INT-108-10
- INT-108-11
- INT-108-12
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Galt Medical Corporation 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 2 products in this recall →Related recalls
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