Reported Sep 27, 2017 · Terminated
Euphora 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?
- Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
- Lot codes and dates
908 of 908 products
Products covered by this recall Model / number Barcodes Product as published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mount recalled
- 69,081 (US)
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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