Medtronic Solarice Balloon Catheter Recall Due to Stylette Removal Difficulty
Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette may cause removal difficulties.
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, and the hazard involves a mechanical difficulty (removal issues) rather than a direct risk of serious injury or death, fitting the Moderate criteria for low-risk or precautionary issues.
Plain-English summary
Medtronic Vascular Galway DBA Medtronic Ireland is recalling 98,675 units of Solarice Rapid Exchange Balloon Dilatation Catheters. The recall covers specific product numbers distributed worldwide.
The recall was initiated because Medtronic determined that some of the catheters have a slightly higher diameter stylette, which is causing removal difficulties. This issue affects the usability of the device during or after the procedure.
Healthcare providers and consumers should stop using the affected catheters and contact Medtronic for further instructions or replacement. The specific product numbers and lot numbers are listed in the official recall documentation.
The recalled product
- Product
- Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X…
- Manufacturer
- Medtronic Vascular Galway DBA Medtronic Ireland
- Affected units
- 98,675
Distribution
Distribution scope not specified by the agency.
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.
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