Medtronic NC Sprinter Balloon Catheter Recalled for Incorrect Size Labeling
Medtronic is recalling 122 units of NC Sprinter Balloon Dilatation Catheters because the compliance chart lists the size as 2.5mm instead of the correct 2.25mm.
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: The recall is classified as Moderate because it involves a minor labeling error on the compliance chart, which falls under the rubric criteria for minor labeling errors.
Plain-English summary
Medtronic Vascular, Inc. is recalling 122 units of the NC Sprinter Rapid Exchange Balloon Dilatation Catheter, Model NCSP22512X. The affected devices are sterile, 2.25 mm in size, and belong to lot number 207002011 with an expiration date of May 13, 2015.
The recall was initiated because the compliance chart included in the lot incorrectly lists the device size as 2.5 mm instead of the correct 2.25 mm. This is a labeling error on the documentation provided with the product.
The affected units were distributed worldwide, including in the United States, Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan, and Thailand. Healthcare providers and distributors should stop using the affected units and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplas
- Manufacturer
- Medtronic Vascular, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 122
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)
- Lot number 207002011
- Exp 5-13-2015.
Distribution
Distribution scope not specified by the agency.
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