Aspiration biopsy needles recalled over undetected deformed atraumatic tips
ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this aspiration needle action as Class I.
Plain-English summary
The ViziShot 2 FLEX single use aspiration needle, model number NA-U403SX-4019, UDI-DI 00821925043060, is being recalled for all lots manufactured after the date given in the recall notice. The tissue biopsy device is made up of four main parts: a handle, a sheath, a needle and a stylet. The recall covers 104,508 units distributed in the United States and in Australia, Germany, Canada, Chile, China, Hong Kong and other countries.
The recall was issued because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I, its most serious category.
Hospitals and endoscopy units holding affected lots should quarantine them and follow the manufacturer's instructions for return.
The recalled product
- Product
- ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable,
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Biopsy Device
- Affected units
- 104,508
Distribution
Distributed nationwide across the United States.
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