Medtronic Sprinter OTW Catheter Luer marking shows incorrect balloon diameter
Medtronic Sprinter OTW Model SPR2512W balloon catheter has incorrect balloon diameter printed on the Luer connection point: 2.25mm instead of correct 2.5mm. Correct specification appears on outer packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error where the device marking shows incorrect diameter specifications, but the correct specification is available on the outer packaging. No illnesses or injuries have been reported, and the actual product distributed is correct. FDA Class II classification with a minor marking discrepancy.
Plain-English summary
Medtronic Inc. is recalling 84 units of the Medline Sprinter OTW Model SPR2512W, an over-the-wire balloon dilatation catheter used in cardiovascular procedures. The device has a coaxial shaft with a balloon mounted on its distal tip.
The Luer connection point on the device is marked with an incorrect balloon diameter of 2.25mm x 12mm, when the correct diameter is 2.5mm x 12mm. The correct specification appears on the product's outer packaging. This marking discrepancy could create confusion about the device's actual specifications.
The recalled units were distributed nationwide throughout the United States. This recall applies to Lot Number 222066656, with an expiration date of April 13, 2023. The FDA classified this as a Class II recall.
If your healthcare facility has received this product, contact Medtronic Inc. for return or disposal instructions. Consult with your facility's supply chain and clinical staff about handling affected inventory.
The recalled product
- Product
- Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
- Manufacturer
- Medtronic Inc
- Hazard
- marking-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN/UPN 00643169850491
- Lot Number: 222066656 Expiration Date: 04/13/2023
Distribution
Distributed nationwide across the United States.
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