ViziShot 2FLEX Aspiration Needle Recalled for Potential Deformed Tips
Olympus Corporation of the Americas is recalling ViziShot 2FLEX Single Use Aspiration Needles (Model NA-U403SX-4019) due to potential deformation of needle tips. The defect may cause unintended tissue trauma during biopsy procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which per the severity rubric establishes a minimum rating of Severe. Although no injuries or deaths have been reported, the potential for undetected needle-tip deformations in a biopsy device poses a direct risk of tissue trauma during medical procedures.
Plain-English summary
Olympus Corporation of the Americas is recalling ViziShot 2FLEX Single Use Aspiration Needles (Model NA-U403SX-4019) worldwide. The recall is due to the potential for undetected deformations in the atraumatic (blunt) needle tips. The ViziShot 2FLEX is a tissue biopsy device consisting of a handle, sheath, needle, and removable stylet.
The defect involves deformation of the needle's atraumatic tip that may go undetected during inspection. An atraumatic tip is designed to minimize trauma to tissue during needle insertion. When the tip is deformed, it may not function as intended and could result in unintended tissue damage or perforation during biopsy procedures.
This recall affects approximately 104,508 units worldwide. All lots of Model NA-U403SX-4019 manufactured after July 29, 2022, are included in this recall. The affected devices were distributed in the United States and internationally to Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, and Singapore.
Healthcare providers using this device should stop using affected units immediately and verify their inventory. Patients who have undergone procedures using this device should contact their healthcare provider if they experience any complications.
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
- Hazard
- device-deformity
- tissue-damage-risk
Distribution
Distributed nationwide across the United States.
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