Recall Roundup: FDA medical device recalls during November

Welcome to Recall Roundup, where we’ll keep you updated on medical device recalls and corrections that the FDA reported over the last month.

Recalls and corrections range from the least dangerous, Class III—which means a product violates FDA law but is “not likely” to be a health hazard—to the most serious in Class I, which means the product poses a high risk of serious injury or death.

The agency posts a list of Class I recalls on its website after the manufacturer takes action. During November, the FDA posted nine Class 1 medical device recalls on its page, including the following.

Anesthesia machine correction. The FDA warned on November 19 that Atlan A350 and Atlan 350XL anesthesia workstations, made by Draeger, have a manufacturing error that could cause mechanical ventilation to fail while they’re in use. Draeger told providers on October 15 to supervise these machines and ventilate patients manually if the machine fails. The company’s October notice said a representative would be in touch with providers for ventilator motor assembly replacement.

Battery pack correction. The FDA reported November 19 that Smiths Medical CADD-Solis rechargeable battery packs can short and melt the pack casing, leaving the battery unchargeable. Smiths Medical urged users on July 16 to check their battery packs—a backup power source for the CADD-Solis ambulatory infusion pump—and report any damage.

Biopsy needle recall. Neurosurgeons, check your needles. If they’re from Elekta’s disposable biopsy needle kit—used with the Leksell Stereotactic System—there may be “microscopic debris” inside some needles. Though the debris is tiny, it could have huge consequences, like entering brain tissue or death, the FDA said on November 29. Elekta advised providers on September 25 to throw out needles from affected lots.

Endoscopic vessel harvesting (EVH) system recall. Getinge’s VasoView HemoPro EVH systems seriously injured at least 17 patients after silicone on the device detached during use, the FDA told medical providers in a November 15 letter. The device, used for vessel harvesting during endoscopies, in three cases created silicone debris that was “unable to be removed.” All the complaints were reported between April 1 and July 31, according to the FDA’s letter. Getinge pulled the HemoPro 1 and 1.5 on September 20.

Hemodialysis correction. Baxter is “in the process of evaluating” whether its AK 98 hemodialysis machines contain certain toxic compounds, the FDA said as of November 29. The company raised the alarm after other companies found toxic compounds in the silicone tubing of similar products. Baxter emphasized in an October 16 letter to providers that they shouldn’t stop dialysis treatment but, if possible, they shouldn’t use AK 98 hemodialysis machines with less than 500 hours of runtime.

Peritoneal dialysis (PD) correction. Baxter is also evaluating if its MiniCap Extended Life PD Transfer Sets contain certain toxic compounds after the compounds were found in similar products from other companies, the FDA said on November 29. Baxter said in an October 21 letter that providers shouldn’t stop dialysis treatment but, if and when possible, should switch to platinum-cured silicone tubing versions of the transfer sets.

Insertion tube recall. One product lot of microTargeting Insertion Tube Sets from FHC contains a reducing cannula that is 20 mm longer than it’s supposed to be. In a kit used to guide instruments during neurosurgery, this manufacturing error could lead to a hemorrhage, brain tissue damage, or death, the FDA said on November 29. FHC told customers to stop using affected needles on October 3.

Intrapulmonary percussive ventilation (IPV) device recall. On October 3, Percussionaire advised customers to discard certain batches of its Phasitron 5 breathing circuits. As of November 1, there have been three reported injuries after patients breathed in potentially dangerous amounts of nickel, the FDA posted.

Ventilator correction. The FDA flagged some models of the Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2, sharing that aerosol deposits can disrupt the device’s internal flow sensor over time, potentially making measurements inaccurate and putting patients at risk of getting too much or too little oxygen. Philips sent out updated use instructions on October 7 and urged users to set up alarms and backup ventilation, among other precautions. Four injuries have been reported as of November 19, according to the FDA.