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Abbott Vascular recalls NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-1
Recalled May 24, 2017 · FDA recall Z-2039-2017 · Abbott Vascular
Hazard
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. · FDA Class I
Units
449,661 units total (132,040 units in US)
Sold at
US and Worldwide
Description
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Product
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
Manufacturer(s)
Abbott Vascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →