Reported Sep 27, 2017 · Terminated
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid…
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, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
- Lot codes and dates
444 of 444 products
Products covered by this recall Model / number Barcodes Product as published SLC2525X00643169680234212610381 SLC3520X00643169680449212610395 SLC1520X00643169680043212610391 SLC2015X00643169680081212610384 SLC2020X00643169680098212621132 SLC2515X00643169680210212610388 SLC2520X00643169680227212621130 SLC4015X00643169680531212610378 SLC27520X00643169680289212621127 SLC27515X00643169680272212621128 SLC3515X00643169680432212621129 SLC3020X00643169680340212663250 SLC22510X00643169680135212671839 SLC3010X00643169680319212663249 SLC22506X00643169680128212671834 SLC2506X00643169680180212671836 SLC2025X00643169680104212671880 SLC37515X00643169680487212671833 SLC32515X00643169680388212671838 SLC4010X00643169680517212671837 - Amount recalled
- 105,633 (OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stylette removal difficulties on the Euphora and Solarice products.
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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