Medtronic Euphora Balloon Catheter Recalled for Stylette Removal Difficulties
Medtronic is recalling Euphora Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 69,081 units distributed in the US and worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any injuries, illnesses, or deaths, and the hazard is a mechanical difficulty (stylette removal) rather than a high-risk pathogen or structural failure causing immediate harm.
Plain-English summary
Medtronic Vascular Galway DBA Medtronic Ireland is recalling the Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The recall is due to stylette removal difficulties on the Euphora and Solarice products.
The recall affects 69,081 units in the United States, including Puerto Rico. The product was also distributed worldwide to numerous countries, including Canada, the United Kingdom, Germany, France, and Australia.
No specific consumer actions or contact information are provided in the source text. Healthcare providers and facilities should identify and remove the affected devices from use.
The recalled product
- Product
- Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
- Manufacturer
- Medtronic Vascular Galway DBA Medtronic Ireland
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 69,081
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medtronic Vascular Galway DBA Medtronic Ireland under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Medtronic Vascular Galway DBA Medtronic Ireland
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- ModerateMedtronic Solarice Balloon Catheter Recall Due to Stylette Removal Difficulty
FDA (Devices) · 2019-10-23
- HighMedtronic Solarice Balloon Catheter Recalled for Stylette Removal Difficulties
FDA (Devices) · 2017-09-27
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