FDA announces class 1 recalls for infusion pumps, anesthesia workstation
Editor's Note Reports of spontaneous backup battery failure in Dreager Inc.’s Perseus A500 anesthesia workstation and multiple failures in InfuTronix, LLC’s Nimbus infusion pump systems prompted the FDA to classify manufacturer recalls as class 1, the most serious categorization indicating risk of serious harm or death. According to an April…
Joint replacement manufacturer recalls products after FDA packaging warning
Editor's Note A January complaint about inefficient packaging for joint replacement products has prompted the manufacturer to recall certain knee and shoulder system devices after initially declining to take the products off the market, according to an April 23 report in Health Exec. The manufacturer, Exactech, is now recalling a…
Gene-edited pig kidney, heart pump combined in transplant surgery milestone
Editor's Note The second-ever living recipient of a gene-edited pig kidney was the first to have the new organ paired with a mechanical heart pump, according to an April 24 CNN report. The subject, 54-year-old Lisa Pisano, underwent the milestone surgery at NYU Langone Health. She had heart failure and…
Catheter sterility concerns prompt Class 1 FDA recall for surgery trays
Editor's Note The US Food and Drug Administration has designated DeRoyal Industries’ recall of GeoMed custom tracecarts a class 1, the most serious type of recall indicating a risk of serious injury or death. According to the April 24 FDA notice, the recall is due to sterility concerns with the…
FDA announces class 1 recalls for premixed embolic, infusion pump software
Editor's Note The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death. No injuries or deaths…
FDA Class 1 recall renews concern about historically problematic heart pumps
The US Food & Drug Administration (FDA) announced a Class 1 recall on Monday for Abbott/Thoratec Corp.’s HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due due to biological material buildup obstructing the devices. According to an April 16 CBS News report, surgeons first noticed problems with the…
FDA: Surgical mesh mini-slings comparable to mid-urethral slings for stress urinary incontinence
Editor's Note Mini-slings for stress urinary incontinence (SUI) are similarly effective to mid-urethral slings over a 36-month timeframe, according to an April 11 announcement from the US Food & Drug Administration (FDA). FDA reached this conclusion after an in-depth, systematic literature review of post-market surveillance (“522”) studies required last year…
Newly FDA-approved microsurgical system holds promise for training, new treatments
Editor's Note The US Food & Drug Administration (FDA) has granted De Novo authorization for marketing MMI North America Inc.’s Symani Surgical System, according to the agency’s April 9 roundup. The system employs a motion scaling function to scale down surgeons movements for procedures requiring small instruments and/or microscopes, such…
Magnetic device controls nanorobots used in surgery
Editor's Note Scientists have found a new way to more precisely control tiny robots used in surgeries using an oscillating magnet. The findings were published in the journal npj Robotics (part of the Nature Portfolio) on March 28. Nanorobots capable of transporting drugs, performing surgical procedures, or taking tissue measurements…
FDA updates warning about plastic syringes made in China
Editor's Note An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality…
Free Daily News
- Augmented reality gains FDA nod, 10k-case milestone in orthopedics, strides in outpatient surgery
- Smart patient selection anchors DISC’s high-acuity spine ASC model
- Postop opioid prescriptions following outpatient surgery see steep, sustained fall
- Study: Bariatric surgery offers cost, survival benefits for cirrhosis patients
- AI monitoring, remote surgery advance
- Rethinking OR routines reduces waste, costs while protecting environment
- Proposed Oregon legislation blocks AI tools from using 'nurse' title
- Communications skills keep surgical patients engaged, informed
- Study: Daytime meals protect heart health in night shift workers
- Borescope inspections reveal widespread contamination in lumened surgical instruments