ev3 TurboHawk Peripheral Plaque Excision System Recall for Incompatible Accessories
Micro Therapeutics is recalling 67 units of the ev3 TurboHawk Peripheral Plaque Excision System because packaged accessories are incompatible with the catheter, potentially preventing the removal of excised material.
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. The hazard involves a functional defect (inability to remove excised material) without reported injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Micro Therapeutics Inc, dba ev3 Neurovascular, is recalling 67 units of the ev3 TurboHawk Peripheral Plaque Excision System for Surgical Use, Large Vessel Extended Tip for Calcium, Model THS-LX-C. The recall involves Lot Number A495368. The product is intended for peripheral vascular use.
The recall is due to a compatibility issue with the Distal Flush Tool (DFT) accessories packaged in this specific lot. These accessories are not compatible with the TurboHawk LX-C catheter. This incompatibility may result in the inability to remove excised material from the tip of the catheter.
The affected units were distributed to the US states of Kansas, California, Florida, Georgia, Arizona, Michigan, Louisiana, Texas, Nebraska, and Kentucky, as well as to China. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Affected units
- 67
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)
- Lot Number A495368
Distribution
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