Dive Brief:
- The Food and Drug Administration posted two early alerts on Tuesday for medical devices that are being removed from the market.
- Teleflex subsidiary Arrow International recalled certain spring wire guide components used as part of a system to place catheters in blood vessels. Arrow told customers on Nov. 5 to quarantine and cease use and distribution for affected products, according to the FDA alert.
- On the same day, the agency posted an alert for Intersurgical, which sent customers a letter on Nov. 3 recommending they immediately stop using certain breathing tubes and systems due to a manufacturing issue.
Dive Insight:
The FDA uses early alerts to notify the public more quickly about medical device safety problems that carry the potential for high risk.
Arrow warned customers about a quality issue that could affect spring wire guide components with a hydrophilic coating. The coating may swell inconsistently when hydrated with saline, according to the FDA notice, causing the coating to clump and the potential for detachment. If the coating detaches, it could increase the risk of a blockage in the blood vessel.
Intersurgical removed certain 22mm Smoothbore breathing tubes and systems due to a manufacturing problem. A solvent is used to bond soft connectors onto the breathing tube, but the company found through an investigation and internal testing that some devices were manufactured with too little solvent to ensure a secure connection.
If a connector detaches while the breathing tube is being used, it could lead to a loss of ventilation, which could cause a patient to desaturate until ventilation is manually restarted, according to the FDA notice. Loss of ventilation could lead to organ failure, brain damage or death, depending on the patient and how long it takes to restart ventilation.
Neither company reported any injuries or deaths related to the recalls at the time they sent letters to customers, according to the FDA notices.
