Medtronic Solarice Balloon Catheter Recalled for Stylette Removal Difficulties
Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 105,633 units distributed 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard involves a mechanical difficulty (stylette removal) in a medical device used for coronary angioplasty, which poses a risk of harm during a procedure, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Medtronic Vascular Galway DBA Medtronic Ireland is recalling the Solarice 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 involves 105,633 units. These products were distributed worldwide, including the United States, Puerto Rico, and numerous international locations. The agency has classified this as a Class II recall.
Healthcare providers should check their inventory for the specific product numbers and lot numbers listed in the recall notice. Patients who have had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Solarice 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
- Affected units
- 105,633
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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