Recall Z-3055-2020— ev3 Inc.

Name: FDA recall Z-3055-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-26

Class II · Terminated

Class II FDA medical device recall by ev3 Inc., initiated 2020-08-26, terminated 2023-06-09. It names one FDA 510(k) clearance: K103464. Product: Pacific Xtreme (PTCA Balloon Dilation Catheter). Reason: Labeling discrepancy for the Rated Burst Pressure (RBP) value..

Recalling firm: ev3 Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-26
Terminated: 2023-06-09
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K103464 — PACIFIC XTREME PTCA BALLOON DILATATION CATHETERMedtronic, Inc.·cleared 2010-12-22

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

Pacific Xtreme (PTCA Balloon Dilation Catheter)

Reason for recall

Labeling discrepancy for the Rated Burst Pressure (RBP) value.

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