Medtronic recalls Solarice Rapid Exchange Balloon Dilatation Catheters with specific product numbers due to a slightly larger stylette that may cause removal difficulties during medical procedures.
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Medtronic is recalling certain Solarice Rapid Exchange Balloon Dilatation Catheters because some have a slightly larger stylette that can make removal more difficult during medical procedures. This issue does not pose a risk of injury but requires careful handling by medical professionals.
The catheters have a slightly larger stylette (the thin metal rod inside) that can cause removal difficulties during medical procedures. This may require additional time or effort to remove the catheter safely, but it does not cause injury.
Medical professionals using the recalled catheters for procedures. Patients using these catheters are not at risk of injury from this issue.
Check the product number on the catheter packaging or label. The recalled product numbers include SLC1506X, SLC1510X, SLC1512X, and other specific codes listed in the recall notice.
Look for the product number on the catheter packaging or label to determine if it is recalled.
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties during medical procedures.
No, the recall does not require stopping use. Medical professionals should check the product number to ensure they are using a recalled model if needed.
Check the product number on the catheter packaging or label to see if it is recalled. If it is, contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0123-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0123-2020 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.
