Medtronic recalls Sprinter OTW catheter model SPR2512W due to incorrect balloon size labeling on the Luer connector. This may lead to improper sizing during procedures. Affected units were sold with specific lot numbers.
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Medtronic is recalling the Sprinter OTW balloon dilatation catheter (model SPR2512W) because the Luer connector incorrectly shows a balloon size of 2.25mmx12mm instead of the correct 2.5mmx12mm. This labeling error could cause improper catheter sizing during medical procedures, potentially leading to complications.
The Luer connector on the catheter shows a balloon diameter of 2.25mmx12mm instead of the correct 2.5mmx12mm. This mismatch could lead to improper catheter sizing during medical procedures, potentially causing complications like inadequate dilation or tissue damage.
Healthcare professionals using the Medline Sprinter OTW catheter model SPR2512W for procedures are most at risk. Patients receiving this catheter during procedures may be affected if the incorrect size causes complications.
Check for the model number SPR2512W on the catheter's packaging or label. Affected units were sold with lot number 222066656 and expired by April 13, 2023.
Look for the model number SPR2512W on the catheter's packaging or label to confirm if it is affected.
The Luer connector incorrectly shows a balloon size of 2.25mmx12mm instead of the correct 2.5mmx12mm, which could lead to improper sizing during procedures.
Check the product label for model number SPR2512W. If affected, contact Medtronic for guidance.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1483-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1483-2022 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.
