Medtronic Recalls PowerCross 0.018 Inch PTA Dilatation Catheters Due to Mislabeling
Medtronic is voluntarily recalling two lots of PowerCross 0.018 inch PTA Dilatation Catheters because the products are mislabeled.
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 FDA Class II and involves a minor labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic is conducting a voluntary urgent medical device recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. The recall is being issued because the product is mislabeled.
The affected product is the ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model AB18W030200150, Sterile EO, Rx Only. The specific lot codes involved are A213373 and A216702. A total of 27 units were distributed, with 25 units in the United States and 2 units in Singapore.
In the United States, the product was distributed in California, Georgia, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Hampshire, New York, Ohio, Pennsylvania, South Dakota, and Texas. Consumers and healthcare providers should check their inventory for these specific lot codes and contact Medtronic or their supplier for further instructions.
The recalled product
- Product
- ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
- Manufacturer
- ev3, Inc.
- Hazard
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 (1)
- A213373 and A216702
Distribution
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