Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2588-2014

July 25, 2014

Class II

Product summary

Firm
Galt Medical Corporation
Event
Event 68939
Status
Terminated
Classification
Class II
Quantity
11,155 units in total
Official record key
device-enforcement:Z-2588-2014

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

Send feedback

We'll only use this to respond to your feedback.