Recall Z-3136-2017— Medtronic Vascular Galway DBA Medtronic Ireland
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: Euphora 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 recordK-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
Euphora 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.