Medtronic recalls Euphora Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. Affected models include EUP1510X, EUP1512X, EUP1515X, EUP2010X, EUP2012X, EUP2015X, EUP22512X, EUP22515X, EUP2510X, EUP2512X, EUP2515X, EUP3010X, EUP3012X, EUP3015X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X, EUP2020X, EUP2030X, EUP2520X, EUP2525X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP3020X, EUP3025X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3525X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP2506X, EUP2530X, EUP22506X, EUP22510X, EUP22515X, EUP22520X, EUP2520X, EUP2525X, EUP27520X, EUP2020X, EUP2025X, EUP2030X, EUP2510X, EUP2512X, EUP2515X, EUP3010X, EUP3012X, EUP3015X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X
Stylette removal difficulties on the Euphora and Solarice products.
Medtronic is recalling Euphora Rapid Exchange Balloon Dilatation Catheters because stylette removal can be difficult. This could lead to complications during medical procedures. Affected models have specific product numbers listed in the recall notice.
Stylette removal difficulties can cause the catheter to become stuck during procedures, potentially leading to complications like vessel damage or the need for additional interventions. However, this is a mechanical issue that does not typically cause serious injury in normal use.
Healthcare professionals using these catheters for procedures like angioplasty are most at risk. Patients using the devices are not directly affected as they are not the ones performing the procedures.
Check the product number on the catheter packaging or label. Affected models include EUP1510X, EUP1512X, EUP1515X, EUP2010X, EUP2012X, EUP2015X, EUP22512X, EUP22515X, E1510X, EUP2510X, EUP2512X, EUP2515X, EUP3010X, EUP3012X, EUP3015X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X, and other variants listed in the recall notice.
Look for the product number on the catheter packaging or label to determine if it is affected.
Stylette removal can be difficult, which may cause the catheter to become stuck during procedures.
Check the product number on the catheter packaging or label. Affected models include EUP1510X, EUP1512X, EUP1515X, EUP2010X, EUP2012X, EUP2015X, EUP22512X, EUP22515X, EUP2510X, EUP2512X, EUP2515X, EUP3010X, EUP3012X, EUP3015X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X, and other variants listed in the recall notice.
No, healthcare professionals can continue using the catheters but should check the product number to confirm if it is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-3136-2017 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-3136-2017 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
