Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system. The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no […]
Recalls
Teleflex warns on some intra-aortic balloon pumps
Teleflex (NYSE:TFX) subsidiary Arrow initiated a voluntary field safety corrective action for some intra-aortic balloon pump devices. According to a safety notice issued in Europe, the devices have a potential issue around short battery run times. The devices can be powered by either an AC power source or battery power. As of Oct. 11, 2022, […]
Medtronic warns on HeartWare HVAD again
Medtronic (NYSE:MDT) recently issued an urgent medical device correction due to potential issues with the HeartWare HVAD. The notice alerts healthcare professionals to safety information related to the controller driveline cover of the HeartWare ventricular assist device (HVAD). Over time, the driveline cover may become hardened. This could create difficulty or the inability to slide the […]
Baxter’s smart incontinence pad recall is Class I
The FDA issued a notice declaring the Baxter (NYSE:BAX) WatchCare incontinence management system (IMS) recall as Class I, the most serious kind. Baxter last month issued an urgent medical device correction for the WatchCare IMS. The system appears to radiate radiofrequency (RF) that may affect other devices on caregivers and patients. The list of potentially […]
More deaths reported in Philips respiratory devices recall
The FDA announced today that it has received more than 90,000 reports of problems — including 260 mentioning deaths — in Philips’ massive respiratory devices recall. It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations. Still, today’s update from the FDA is but another reminder of the […]
Philips’ respiratory devices recall has even more problems
The FDA says some Philips ventilators — reworked as part of the company’s massive respiratory device recall — have new problems. The Dutch medtech giant has informed the FDA that reworked Philips Respironics Trilogy ventilators have two new potential issues, the FDA said last week. Philips followed up today with a news release that said […]
FDA says Insulet Omnipod Dash batteries recall is Class I
The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level. Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. The […]
Insulet issues device correction on Omnipod 5 controller due to charging issue
Insulet (Nasdaq:PODD) announced a medical device correction for its Omnipod 5 automated insulin delivery system. Acton, Massachusetts-based Insulet’s correction relates to an issue with the Omnipod 5 controller’s charging port and cable. The correction does not impact the Omnipod 5 pod, the previous-generation Omnipod Dash and Omnipod, or compatible Android smartphone devices with the Omnipod 5 […]
Insulet warns of battery issues with some Omnipod Dash PDM devices
Insulet (Nasdaq:PODD) recently issued a voluntary global safety notice to warn of battery problems with its Omnipod Dash system. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. Insulet’s notice went out to current and past users of the Omnipod Dash […]
Teleflex has a serious breathing circuit bacterial filters recall
The FDA this week said the Teleflex (NYSE:TFX) recall of some Gibeck Iso-Gard bacterial and viral filters is a Class I recall, the most serious kind. Teleflex is recalling several types of the Iso-Gard Filter S after receiving reports that the filter may split or become detached from breathing systems. Iso-Gard Filter S filters are […]
Baxter’s smart incontinence pad system has an RF problem
Baxter (NYSE: BAX) recently announced an Urgent Medical Device Correction for its WatchCare incontinence management system. The Oct. 21 announcement said that the WatchCare system was meant to comply with the most recent radio frequency standards. However, it appears to radiate RF that may affect other devices on caregivers and patients. In all but two […]
