Medtronic recalls Euphoria Rapid Exchange Balloon Dilatation Catheters with product numbers EUP1506X through EUP4030X due to a slightly higher diameter stylette that can cause removal difficulties during procedures.
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Medtronic is recalling certain Euphoria Rapid Exchange Balloon Dilatation Catheters because some have a stylette with a slightly higher diameter that can make removal difficult during medical procedures. This does not pose a risk of injury to users but requires careful handling.
The catheter's stylette (a small metal rod inside the catheter) has a slightly higher diameter than intended, which can cause it to be harder to remove during medical procedures. This does not cause injury but may require additional effort or specialized techniques.
Patients and medical professionals who use the recalled catheters for procedures like angioplasty. The risk is minimal as the issue only affects removal during procedures, not during use.
Check the product number on the catheter packaging or label. The affected models range from EUP1506X to EUP4030X, including specific lot numbers listed in the recall notice.
Look for the product number on the catheter's packaging or label. Affected models include EUP1506X through EUP4030X with specific lot numbers.
No, the recall is for a stylette that may be harder to remove during procedures, not a risk of injury during normal use.
Check the product number on the catheter's packaging or label. Affected models range from EUP1506X to EUP4030X with specific lot numbers listed in the recall notice.
No action is needed if your catheter is not in the affected product numbers listed.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0122-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0122-2020 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.