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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
See all →- SevereMedtronic Confida Expandable Sheath Recalled for Vascular Complication Risk
FDA (Devices) · 2020-06-03
- HighMedtronic Euphoria Balloon Catheters Recalled for Stylette Removal Difficulties
FDA (Devices) · 2019-10-23
- 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
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
Similar recalls
- HighMedtronic Euphoria Balloon Catheters Recalled for Stylette Removal Difficulties
FDA (Devices) · 2019-10-23
- ModerateMedtronic Solarice Balloon Catheter Recall Due to Stylette Removal Difficulty
FDA (Devices) · 2019-10-23
- HighCordis EMPIRA RX PTCA Dilatation Catheter Recalled for Balloon Cover Removal Issues
FDA (Devices) · 2014-09-03
- HighCordis EMPIRA NC RX PTCA Dilatation Catheter Recalled for Balloon Defect
FDA (Devices) · 2014-09-03
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05