TyTek PneumoDart Decompression Device: Updated Instructions for Needle Placement
Tytek Medical is updating instructions for the TyTek PneumoDart to better identify needle decompression risks and improve placement guidance. Approximately 22,026 units distributed before October 5, 2020 are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device used for emergency decompression in tension pneumothorax. Although no injuries have been reported, the recall addresses critical gaps in identifying needle decompression risks and providing proper placement guidance—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The TyTek PneumoDart (Model TM-317) is a medical device designed to remove air from the pleural cavity in patients with tension pneumothorax. Tytek Medical is updating the device's Instructions for Use (IFU) to address gaps in safety communication.
The updated IFU will better identify the risks associated with needle decompression and provide improved artwork showing the correct placement site location. These enhancements are intended to ensure proper use of this emergency decompression device.
Approximately 22,026 units distributed prior to October 5, 2020 are affected. The device has been distributed in Ohio, South Carolina, and Virginia, as well as internationally in Australia, Denmark, Finland, Germany, Hong Kong/China, Israel, Spain, the Netherlands, Turkey, the UAE, and the UK. Healthcare facilities using this device should review the updated instructions.
The recalled product
- Product
- TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
- Manufacturer
- Tytek Medical Inc
- Hazard
- needle-decompression
- improper-placement
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 (2)
- UDI: 00855204008167 All lots produced prior to Oct 5
- 2020
Distribution
Distributed in 3 states:
- OH
- SC
- VA
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