Reported Oct 23, 2019 · Ongoing
Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X,…
Medtronic Vascular Galway dba Medtronic Ireland
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular Galway DBA Medtronic Ireland · Parkmore Business Park West · Galway, N/A · N/A
Is this the product you have?
- Solarice Rapid Exchange Balloon Dilatation Catheter
- Product Numbers
SLC1506XSLC1510XSLC1512XSLC1515XSLC1520XSLC2006XSLC2010XSLC2012XSLC2015XSLC2020XSLC2025XSLC2030XSLC22510XSLC22515XSLC22520XSLC22525XSLC2506XSLC2510XSLC2512XSLC2515XSLC2520XSLC2525XSLC2530XSLC27512XSLC27515XSLC27520XSLC3010XSLC3012XSLC3015XSLC3020XSLC3025XSLC3030XSLC3506XSLC3510XSLC3512XSLC3515XSLC3520XSLC3530XSLC4010XSLC4012XSLC4015XSLC4020XSLC4025XSLC4030X (OUS DISTRIBUTION ONLY)
- Lot codes and dates
222 of 222 products
Products covered by this recall Model / number Barcodes Product as published SLC1506X00643169680005217427355 SLC1510X00643169680012217253572 SLC1510X00643169680012217298666 SLC1510X00643169680012217387126 SLC1510X00643169680012217427354 SLC1510X00643169680012217487816 SLC1512X00643169680029217218112 SLC1512X00643169680029217253582 SLC1512X00643169680029217387128 SLC1512X00643169680029217487818 SLC1512X00643169680029217542634 SLC1512X00643169680029217859789 SLC1515X00643169680036217246455 SLC1515X00643169680036217253577 SLC1515X00643169680036217306789 SLC1515X00643169680036217415822 SLC1515X00643169680036217427365 SLC1515X00643169680036217823443 SLC1515X00643169680036217859165 SLC1515X00643169680036217940024 - Amount recalled
- 98675 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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