Abbott has recalled more than 155,000 implantable pulse generators (IPGs) due to a Bluetooth connectivity flaw that has left some devices unusable. The Class I recall — the FDA’s most serious level — covers Proclaim and Infinity IPGs used for three kinds of neurostimulation: Spinal cord stimulation: Proclaim XR 5 IPG Model 3660 (previously known […]
Recalls
Philips reaches settlement in class-action lawsuit over sleep apnea machine recall
Philips announced today that it reached a class-action settlement on economic loss claims related to its ongoing Respironics recall. The agreement resolves all economic loss claims in the U.S. multidistrict litigation (MDL) related to the voluntary recall. Philips expects to submit the settlement to the U.S. District Court for the Western District of Pennsylvania later […]
Draeger Medical has another serious ventilator recall
This week, the FDA labeled Draeger’s recall of some ventilators as Class I, the most serious kind. Draeger issued a voluntary correction, not a product removal, of specific Carina sub-acute care ventilators. The company said clinicians may continue to use the devices with adult patients and are instructed not to use the devices with pediatric […]
Philips warns on potential unintended radiation with imaging systems
Philips issued an urgent field safety notice in Europe regarding a potential issue with some of its imaging systems. The issue pertains to the wired and wireless foot switches used with the Philips Allura Xper, Allura Centron, Azurion and the MultiDiagnost-Eleva systems. It could lead to unintended radiation, according to the notice filed in Europe […]
FDA deems latest Abiomed Impella recall Class I
Abiomed, a Johnson & Johnson unit, issued another recall for some of its Impella heart pumps. This marks the third safety notice regarding the heart pumps in as many months. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge […]
Medtronic’s third recall of Mahurkar hemodialysis catheters is Class I
The FDA has labeled the Medtronic recall of some Mahurkar hemodialysis catheters as Class I, the most serious kind. Medtronic is recalling its Mahurkar 12 Fr high-pressure triple lumen acute dialysis catheters in 20 cm length with curved extensions due to occlusions in the tip of the catheter. The company said the source of the […]
Philips Respironics has a Class I level ventilators recall
The FDA has posted information on its website about another serious recall involving Philips Respironics products. The news comes the same week that Philips got a vote of confidence from Exor, the investment arm of Italy’s wealthy Agnelli family, which bought a 15% stake in the Dutch medtech giant to become its largest shareholder. Media […]
Getinge subsidiary Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice labeling another recall of Getinge subsidiary Datascope’s Cardiosave pump as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs). Both devices were subject to two separate Class I recalls in March. The company also initiated a Class I […]
Integra Lifesciences expects to resume manufacturing in Boston
Integra LifeSciences (NASDAQ: IART) recently announced that it plans to resume manufacturing in its Boston facility by the end of the fourth quarter. Just two months before, Integra voluntarily recalled all tissue-related products made in Boston and distributed between March 1, 2018 and May 22, 2023. The recalled products included SurgiMend, PriMatrix, Revize and TissueMend. […]
Baxter warns on some infusion pumps due to potential false alarms
Baxter (NYSE:BAX) issued an urgent medical device correction for some Spectrum V8 and Spectrum IV infusion pumps in the U.S. The FDA later issued a notice identifying the recall as Class I, the most serious kind. Baxter recalled 22,769 devices in total. Affected pumps in the U.S. and Puerto Rico received upgrades to software versions […]
GE HealthCare has a serious recall of its TruSignal SpO2 sensors
The FDA issued a notice labeling the GE HealthCare SpO2 sensor recall as Class I, the most serious kind. GE HealthCare initiated the recall of nine models of its TruSignal SpO2 sensor on May 19, 2023. The recall includes 7,559 devices distributed between Jan. 1, 2021, and March 4, 2023. A GE HealthCare spokesperson shared […]