Recall Z-3137-2017— Medtronic Vascular Galway DBA Medtronic Ireland

Name: FDA recall Z-3137-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-13

Class II · Terminated

Class II FDA medical device recall by Medtronic Vascular Galway DBA Medtronic Ireland, initiated 2017-07-13, terminated 2020-08-19. It names one FDA 510(k) clearance: K143480. Product: Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.. Reason: Stylette removal difficulties on the Euphora and Solarice products..

Recalling firm: Medtronic Vascular Galway DBA Medtronic Ireland
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Terminated: 2020-08-19
Firm location: Galway, N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K143480 — Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc.·cleared 2015-04-02

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

Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

Reason for recall

Stylette removal difficulties on the Euphora and Solarice products.

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