Medtronic Euphoria Balloon Catheters Recalled for Stylette Removal Difficulties
Medtronic is recalling Euphoria Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette causes 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 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, and the defect causes removal difficulties in a medical device, representing a risk of harm where injury has not yet been reported in the source text.
Plain-English summary
Medtronic Vascular Galway DBA Medtronic Ireland is recalling 53,137 units of Euphoria Rapid Exchange Balloon Dilatation Catheters. The affected product numbers include a wide range of EUP series identifiers, such as EUP1506X, EUP2010X, and EUP4030X. The recall is classified as Class II by the FDA.
The recall was initiated because Medtronic determined that some of the catheters have a slightly higher diameter stylette, which causes difficulties during removal. The source text does not specify the number of reported injuries or illnesses associated with this defect.
The affected units were distributed worldwide. Healthcare providers and consumers should check their inventory for the specific product numbers and lot numbers listed in the official FDA recall notice Z-0122-2020. If you have these devices, you should contact Medtronic or the FDA for instructions on how to proceed.
The recalled product
- Product
- Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X…
- Manufacturer
- Medtronic Vascular Galway DBA Medtronic Ireland
- Hazard
- Affected units
- 53,137
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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