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Recall Observatory FDA recall evidence

Device product

GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Z-2589-2014

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-2589-2014

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: Catalot Numbers: KIT-043-06, KIT-043-07, KIT-043-08, KIT-043-09, KIT-043-10, KIT-043-11, KIT-053-06, KIT-053-07, KIT-053-08, KIT-053-09, KIT-053-10, KIT-053-11, KIT-053-12, KIT-053-17, KIT-053-18, KIT-053-19, KIT-053-20, KIT-053-21, and KIT-053-22

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.