Welcome to Recall Roundup, where we keep you updated on the FDA’s medical device recalls from the last month.
Recalls range from making tweaks to pulling a device from the market altogether. First, the manufacturer takes action, then the FDA categorizes them from Class III (least dangerous) to Class I (most dangerous).
The FDA posts a list of the most serious recalls on its website, along with early alerts for things that may be labeled Class I recalls later on.
The FDA shared one Class II recall, 10 Class I recalls, and one early alert in March.
Atherectomy catheter system issue. There have been 30 serious injuries, four deaths, and 115 cases “requiring additional intervention” reportedly linked to Rotarex atherectomy catheter systems from Becton, Dickinson and Company’s subsidiary Bard Peripheral Vascular. The company said the device can still be used but the helix component may fracture or break with certain patient anatomies. It’s still investigating what else could cause helix breakage, but has updated use instructions, online training, and warnings for now. The FDA first issued a Feb. 6 early alert then upgraded this to a Class I recall on March 5.
Embolization device exit. Medtronic Neurovascular pulled one device and updated use instructions for another. These devices attach to blood vessel walls as part of a treatment for brain aneurysms, but they’ve been failing to attach or stay attached, the FDA reported on March 18. Its 027 model-compatible pipeline vantage embolization devices are off market after 13 reported injuries and four reported deaths, and the 021 model has new instructions following four reported injuries.
Endotracheal tube recall. Smiths Medical has told customers to destroy certain lots of oral/nasal endotracheal tubes because their diameter is too small. This could mean patients won’t get enough ventilation, potentially leading to organ failure, heart attack, or death. There have been eight injuries reported, the FDA said on March 25.
Endovascular system recall. Philips Image Guided Therapy Services has pulled its Tack Endovascular System from the market after warning customers in January not to use it anymore. The product, meant to repair dissected blood vessels, has reportedly injured 20 and can cause occlusion, dissection, perforations, pain, tissue loss, and even amputation or death. There have been no reported deaths as of March 3, according to the FDA.
Implantable ports pulled. Some lots of Smiths Medical ProPort plastic implantable ports, which are used in systems to access veins, have been pulled from circulation after receiving reports of a manufacturing defect linked to parts of the port splitting either before, during, or after implantation. There have been two reported injuries, the FDA said on March 19.
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Infusion pump issue. Baxter Healthcare Corporation has asked providers to return certain Spectrum infusion pumps for inspection and reservicing after someone reported a serious injury due to a missing motor mounting screw. The FDA issued an early alert on March 5 then labeled this a Class I recall as of March 20.
Infusion pump software update. The FDA upgraded a December early alert for Fresenius Kabi USA’s Ivenix Infusion System to a Class I recall on Feb. 4. Fresenius Kabi is warning customers to update its large-volume pump software to version 5.10 to fix a glitch that risks under- or over-infusing patients with therapy. The good news: There have been no injuries or deaths reported, the FDA said on March 5.
(Another) Infusion pump software update. Becton, Dickinson and Company and subsidiary CareFusion warned customers to check and update their BD Alaris Systems Manager and BD Care Coordination Engine (CCE) Infusion Adapter. Its software has issues that could lead to delays and inaccurate dosing information, which could lead to patients getting too much or too little therapy, the FDA said on March 20. There have been no reported injuries or deaths.
Solution sets scrapped. Though the FDA generally only posts about Class I recalls on its medical recall page, it shared on March 5 that it had upgraded a December early alert to a Class II recall. This all started on Dec. 20, when Baxter Healthcare told customers to stop using its solution sets with duo vent spikes because they weren’t properly assembled. Medication may not get properly delivered to a patient’s bloodstream or patients could lose blood with these faulty sets.
Vaporizer recall. In an expansion of a Class I recall from 2024, Getinge has recalled vaporizers with certain serial numbers. These devices are used in starting and maintaining general anesthesia. They have the potential to produce toxic hydrogen fluoride when used with low water content sevoflurane manufactured by Piramal or Baxter, though there have been no injuries or deaths reported, the FDA said on March 3.
Vascular cannula recall. Medtronic has told customers not to use certain lots of aortic root cannulas, which are devices used during or after a cardiopulmonary bypass, because they may contain loose material that can become dislodged. The FDA said on March 31 that there have been no reported injuries or deaths.
Early alerts. The FDA has issued an early alert for CVAC aspiration systems from Calyxo.