Galt Medical Corporation: Medical Device Recall in 2014 - (Recall #: Z-2588-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 25, 2014

Date Posted: September 10, 2014

Recall Number: Z-2588-2014

Event ID: 68939

Reason for Recall:

The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.

Status: Terminated

Product Quantity: 11,155 units in total

Code Information:

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, INT-108-17, INT-108-18, INT-108-19, INT-108-20, INT-108-21, INT-108-22, INT-108-22, VTI-002-06, VTI-002-07, VTI-002-08, VTI-002-09, VTI-002-09, VTI-002-10, VTI-002-11, VTI-002-12, VTI-002-17, VTI-002-18, VTI-002-19, VTI-002-20, VTI-002-21, VTI-002-22, VTI-002-23, VTI-003-06, VTI-003-07, VTI-003-08, VTI-003-09, VTI-003-10, VTI-003-11, VTI-003-12, VTI-003-17, VTI-003-18, VTI-003-19, VTI-003-20, VTI-003-21, VTI-003-22, and VTI-003-23.

Distribution Pattern:

Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.

Voluntary or Mandated:

Voluntary: Firm initiated