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.
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, 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
Related recalls
Same manufacturer · Ev3, Inc.
See all →- HighMedtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation
FDA (Devices) · 2025-01-22
- SevereMedtronic TurboHawk Plus atherectomy system recalled for potential tip detachment
FDA (Devices) · 2022-03-16
- SevereMedtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect
FDA (Devices) · 2022-03-16
- SevereMedtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage
FDA (Devices) · 2022-01-26
- CriticalMedtronic HawkOne Atherectomy System Recalled for Tip Detachment and Embolization Risk
FDA (Devices) · 2022-01-26
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02