Shares of Getinge (STO:GETI-B) dropped 5% today on news that the FDA had received 60 more reports of adverse events — including two deaths and one serious injury — related to the company’s Maquet/Datascope intraortic balloon pumps (IABP). The FDA said the new reports have come in since it issued a letter in November 2018 […]
Maquet recalls arterial filters
Getinge subsidiary Maquet Cardiovascular is recalling its Quart arterial filter, used during coronary bypass surgery, because transportation may compromise its sterile packaging. A transportation simulation test revealed the problem, according to an August 27, 2019, letter to customers. Patients who are exposed to non-sterile medical devices while undergoing extracorporeal circulation may develop an infection and […]
Getinge recalls cardiac pumps following reports of 5 deaths
Getinge (STO:GETI-B) is recalling four models of Maquet/Datascope intra-aortic balloon pumps (IABP) due to reports of faulty batteries. Five deaths have been reported since March 2016. The IABP batteries failed to hold a charge, stopped unexpectedly, or had a shortened run-time, which may have caused the device to stop working when being operated by battery […]
Getinge launches new surgical table in U.S.
Getinge (STO:GETI-B) today announced the U.S. launch of its Maquet Yuno II surgical table, which the company touts as a versatile option to support advanced orthopedic techniques. Officials at the Swedish medical device company the table — with its multiple configurations supporting a variety of procedures — could also reduce the complexity of setup for […]
FDA warn’s Getinge’s Datascope about ongoing IABP issues
The FDA recently revealed a warning letter it sent to Getinge‘s (PINK:GETI B) Datascope over ongoing issues uncovered during an inspection of its Mahwah, N.J.-based intra-aortic balloon pump production facilities last year, noting a number of continuing quality and validation issues that have not yet been appropriately managed. The federal watchdog said that it has received […]
Google taps ex-Geisinger CEO Feinberg to lead consolidated Google Health biz | Personnel Moves – November 14, 2018
Google (NSDQ:GOOG) has picked up former Geisinger Health CEO David Feinberg to lead its fragmented health divisions under the Google Health moniker, according to a recent CNBC report. The tech giant had been searching for a head for several months, with artificial intelligence head Jeff Dean heavily involved in the process, according to the report. Other […]
FDA warns of battery shutdown issues with Getinge’s Maquet/Datascope IABPs
The FDA this week posted a letter to healthcare providers warning of reports that Getinge‘s (PINK:GETI B) Datascope and Maquet intra-aortic balloon pumps are shutting down while running on battery power, which could result in serious injury or death. The company’s intra-aortic balloon pump is designed to be implanted in the descending aorta distal to the left subclavian […]
Getinge’s Atrium Medical deals biosurg biz to SeCQure Surgical parent
Getinge (PINK:GETI B) subsidiary Atrium Medical said today that it agreed to deal its biosurgery business to the parent company of SeCQure Surgical for an undisclosed amount. Göteborg, Sweden-based Getinge acquired the biosurgery unit, which makes soft tissue reinforcement devices, in the $680 million deal for Atrium back in 2011. Today Getinge said it agreed to sell the business, which […]
FDA warns Getinge’s Datascope over IABP production facility issues
The FDA this week released a warning letter it sent to Getinge‘s (PINK:GETI B) Datascope over issues it found during an inspection of its Fairfield, N.J.-based facilities used to manufacture intra-aortic balloon catheters. During the inspection, which took place between March 19 and June 11 this year, the FDA said that it identified five different instances […]
Getinge slips Abiomed counter-claim in patent spat with Maquet subsidiary
Getinge (PINK:GETI B) yesterday slipped out of a counter-suit filed by Abiomed (NSDQ:ABMD) against its Maquet subsidiary in an infringement spat over a blood pump patent. Danvers, Mass.-based Abiomed initially sued Maquet in May 2016, asking Judge Dennis Saylor of the U.S. District Court for Massachusetts for a judgment of non-infringement of a trio of patents; counter-suits later brought […]
FDA labels IABP recall for Getinge’s Maquet, Datascope as Class I
The FDA today labeled a select recall of Getinge‘s (PINK:GETI B) Datascope and Maquet Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The Cardiosave hybrid intra-aortic balloon pump is designed […]
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