Medical device recalls, whether voluntary or mandated by the FDA, ensure patient safety. Nineteen medical supply recalls reported by Becker's Hospital Review since June 25:
- The FDA has recalled all ultrasound gels and lotions made by Eco-Med Pharmaceuticals because of the risk of bacterial contamination with Burkholderia cepacia complex. The gels and lotions have been associated with at least 66 infections, including 60 bloodstream infections. Eco-Med has shut down all operations and is no longer manufacturing or distributing any products.
- Armstrong Medical Ltd. recalled its Amsorb Plus prefilled cans, which contain a chemical substance used in anesthesia machines to absorb carbon dioxide the patient breathes out while under anesthesia. The company received reports that some of the prefilled cans have difficulties with gas flow that may cause a reduced airflow to the patient. If not addressed, this issue could prevent a ventilator from providing enough breathing assistance to the patient, which could cause a buildup of carbon dioxide in the patient's body and result in negative health effects. There have been no injuries or deaths reported related to the recall.
- Cordis recalled its Super Torque angiographic catheter, which is used to visualize and measure parts of the vascular system, because of the potential for the marker bands to move or dislodge during procedures. If this happens, it could cause serious adverse events, including heart attack or stroke. There have been 167 complaints, eight injuries and no deaths reported related to the recall.
- Medtronic recalled a brain aneurysm stent device because of a risk of malfunction that has been linked to 10 serious injuries and two deaths.
- Smiths Medical recalled its Normoflo irrigation fluid warmer and Normoflo irrigation warming set, which are used for warming blood, blood products and intravenous solutions before use, because of the potential for aluminum ions leaching into the fluids, meaning a patient could be exposed to high levels of aluminum. Exposure to toxic levels of aluminum can cause serious adverse events and death. There have been no complaints, injuries or deaths reported related to the recall.
- Magellan Diagnostics expanded its recall of blood lead tests, which was initiated in May after the company identified an ongoing issue with the controls used in the tests.
- Cardinal Health recalled 267 million monoject flush prefilled saline syringes after finding the plunger may pull back and reintroduce air into the syringe, which can cause serious adverse outcomes. Cardinal has received 37 reports of the plunger pulling back, but no injuries had been reported as of Aug. 19.
- Bio-Medical Equipment Services recalled its Alaris infusion pump model 8100 after finding the bezel components may crack or separate, leading to inaccurate delivery of fluids to patients, which could cause serious patient harm. The Alaris pump is used to deliver fluids such as medications, nutrients and blood to a patient in controlled amounts. There have been no deaths, complaints or injuries reported for the recall.
- Cardinal Health recalled its Argyle UVC insertion tray, which is used during a procedure for critically ill newborns, after finding it doesn't include specific instructions about the scalpel's permanent locking feature. Cardinal Health has received two reports of patient deaths after the scalpel locked permanently and the clinician was unable to unlock it for use during an emergency procedure. But Cardinal Health said in a statement that the causes of deaths haven't been established to be a result of the scalpel being locked. Cardinal has also received 10 complaints about the device issue.
- Baxter Healthcare recalled its Dose IQ safety software, which allows providers to create a drug library of preprogrammed dosing information for specific medications delivered using the Spectrum IQ infusion pump. Baxter recalled the software after finding a defect that may lead to mismatched drug information in the drug libraries. If the software's drug identifier doesn't match the information in the pump, the drugs may be improperly configured and cause serious adverse events, including delay in therapy, underinfusion or overinfusion of the drug. There have been 15 complaints reported for the issue, but no injuries or deaths.
- Boston Scientific recalled its Ingenio pacemakers and its CRT-Ps because of a risk of the devices transitioning to safety mode. In safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device goes into safety mode, it can't be reprogrammed and must be replaced. There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing. There have been no reports of death.
- Eight Medical International recalled its recirculator 8.0 disposable lavage kit, which is used with its hyperthermic perfusion system. The kit allows the perfusion system to circulate sterile solution inside a patient's chest or abdominal cavity to reach a target temperature during surgery. The company recalled the kit because it may release aluminum into the fluid, potentially exposing patients to high levels of aluminum, which can be toxic and cause serious adverse events, including death. There have been no complaints, injuries or deaths reported.
- Philips recalled its V60 and V60 Plus ventilators because of a risk of the device reaching its default maximum limit, which can happen if the oxygen flow is partially blocked for any reason. For patients who need high-flow oxygen therapy, if the issue is not resolved, the ventilator will continue to provide the patient with a lower oxygen flow rate than necessary and issue a low-priority alarm. There have been 61 incidents, 25 injuries and no deaths stemming from the issue.
- Philips recalled its continuous and noncontinuous ventilators because the foam used to reduce sound and vibration in the devices may break down and enter the device's air pathway and be inhaled or swallowed by the person using the device. There have been more than 1,200 complaints and more than 100 injuries reported for the issue.
- Vero Biotech recalled its nitric oxide delivery system, which is used to deliver a drug to help open blood vessels and improve oxygen levels in critically ill newborns with respiratory failure. The device was recalled because of a software issue that leads to errors in the delivery of nitric oxide, which has caused 11 complaints, three injuries and no deaths.
- Quidel recalled its Lyra COVID-19 test because of a "significant" risk of false negative results in people infected with high amounts of the virus. There have been five complaints related to the issue, but no injuries or deaths.
- Medtronic recalled its guidewire used to help place catheters in the vasculature after finding the devices weren't sterilized before being shipped to hospitals. There have been two complaints, but no injuries or deaths reported related to the issue.
- Avid Medical recalled its medical supply kits, citing a risk of contamination with the fungus Aspergillus penicillioides from one of the devices in the kit. There have been no complaints, injuries or deaths reported related to the issue.
- DeRoyal Industries recalled its surgical procedure packs, which include a set of devices used for routine cardiac procedures, after finding that the packs contain lidocaine that has been mislabeled as a different dosage of bupivacaine. There have been no complaints, injuries or deaths reported related to the issue.