Ev3 Recalls EverCross PTA Dilatation Catheters Due to Labeling Error
Ev3 is recalling two lots of EverCross PTA Dilatation Catheters because of a discrepancy in the balloon and delivery catheter lengths printed on the product labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text identifies the issue as a labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Ev3, Inc. is recalling two production lots of EverCross 0.035" OTW PTA Dilatation Catheters. The recall involves 39 units, with 31 distributed outside the United States and 8 within the US.
The reason for the recall is a product labeling error. There is a discrepancy between the PTA Balloon length and the delivery catheter length printed on the product labeling. The affected reference numbers are AB35W06120135 and AB35W06040080, both with a use-by date of January 16, 2017.
The products were distributed worldwide, including in the United States (specifically WV, TX, OK, IN, NY, and NC) and in Australia, Israel, Turkey, the United Kingdom, Italy, France, and China. Healthcare providers should stop using these specific lots and contact Ev3, Inc. for further instructions.
The recalled product
- Product
- ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
- Manufacturer
- Ev3, Inc.
- Category
- Medical Device — Catheter
- Hazard
Distribution
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