Galway, N/A, Ireland
Medtronic Vascular Galway DBA Medtronic Ireland recalls
2 recalls recorded since 2018, most recently on 12 May 2020. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 12 May 2020
- Terminated
- 10 March 2022
- Reason
- Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
- Distribution
- US distribution in TX, WI, CA, NY, AL, and MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2039-2020
- Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Ongoing Class II Medical devices
- Recall started
- 3 September 2019
- Reason
- Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0123-2020, Z-0122-2020
- Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC2252
- Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP2251
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.