Recall Z-1095-2022— Abbott Vascular

Name: FDA recall Z-1095-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-30

Class I · Ongoing

Class I FDA medical device recall by Abbott Vascular, initiated 2022-03-30. It names one FDA 510(k) clearance: K192019. Product: Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO. Reason: There is a potential that the proximal marker may separate from the imaging catheter.

Recalling firm: Abbott Vascular
Classification: Class I
Status: Ongoing
Initiated: 2022-03-30
Firm location: Temecula, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K192019 — Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1ABBOTT MEDICAL·cleared 2019-11-08

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

Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

Reason for recall

There is a potential that the proximal marker may separate from the imaging catheter

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