Recall Z-2039-2017— Abbott Vascular

Name: FDA recall Z-2039-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-22

Class I · Terminated

Class I FDA medical device recall by Abbott Vascular, initiated 2017-03-22, terminated 2018-02-07. It names one FDA 510(k) clearance: K103153. 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. Reason: 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..

Recalling firm: Abbott Vascular
Classification: Class I
Status: Terminated
Initiated: 2017-03-22
Terminated: 2018-02-07
Firm location: Temecula, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K103153 — VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETERAbbott Vascular-Cardiac Therapies·cleared 2010-12-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.