Are you curious about all the ways that multimillion-dollar medical tech can go wrong? Do you ever notice a medical device that has been taken out of rotation, and wonder why? Or are you simply bored and looking for something to read?
If your answer is yes to any of those questions, then welcome to Recall Roundup, where we’ll keep you updated on medical device recalls posted over the last month.
Recalls range from correcting an issue to removing a device from the market altogether. They range from Class III to Class I, arranged respectively from least to most dangerous. Class I means the product poses a high risk of serious injury or death.
The FDA posts a list of Class I recalls on its website after the manufacturer takes action. The agency also posted early alerts for potential high-risk recalls or corrections as part of a new pilot program, announced November 21.
These early alerts involve informing consumers of potentially risky device defects and measures like market removals, even though “the FDA may not yet have determined that the actions meet the regulatory definition of a recall,” according to the agency’s website.
The FDA posted three new medical device recalls and six early alerts in December.
Catheter correction. The FDA reported there have been seven reported injuries and four deaths linked to Boston Scientific’s POLARx cryoablation system, including POLARx and POLARx FIT cryoablation catheters and the SMARTFREEZE cryo-console. This device is used to cryogenically freeze heart tissue that causes irregular heartbeats in order to treat atrial fibrillation. Boston Scientific warned on October 10 that “a higher than anticipated” number of esophageal injuries were reported, and updated its use instructions to reduce that risk going forward.
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Infusion pump battery recall. Here’s a shocking one: Batteries in some Plum 360, Plum A+, and Plum A+3 infusion systems may be counterfeit. ICU Medical warned customers in an October 22 letter to check if their pump’s battery is made by ICU medical. The letter included instructions on how to identify the batteries through the labeling. In an alert update on December 20, the FDA shared that the counterfeit batteries may fail to hold a charge and need to be replaced earlier than expected, putting patients at risk of the device failing. There have been no reported injuries or deaths.
Syringe recall. The FDA reported on December 4 that certain product code and lot numbers of Cardinal Health’s Monoject U-100 mL insulin syringe luer lock with tip cap soft packs aren’t compatible with needleless IV connectors. This means that when these connectors are used to administer IV push insulin, they might not give the full dose, Cardinal Health warned in a September 25 letter.
Early alerts. The FDA also issued early alerts for potential issues with certain models or lots of an infusion pump from Fresenius Kabi USA, a nephroscope sheath from Trokamed GmbH, endoscope accessories from Olympus, an extracorporeal blood circuit from Nuwellis, a solution set from Baxter Health Corporation, and a fluid delivery set from Medline.