The FDA today sent a letter to health care providers and facilities expressing “continued safety and quality concerns” about Getinge/Maquet cardiovascular medical devices. The warning covers Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets. “The FDA continues to receive medical device reports (MDR) related to […]
Maquet Cardiovascular LLC
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 […]
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 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 […]
FDA clears FloPump 32 from International Biophysics
International Biophysics said today that it won 510(k) clearance from the FDA for its FloPump 32 centrifugal disposable heart pump, designed for use with Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular‘s RotaFlow console. Austin, Texas-based International Biophysics tout The FloPump 32 as one of the smallest centrifugal pumps in the world at 32ml prime. “With this FDA clearance of […]
Maquet opens a new front in patent war with Abiomed
Getinge (PINK:GETI B) subsidiary Maquet opened a new front last week in its patent war with Abiomed (NSDQ:ABMD), alleging infringement of a patent granted earlier this year. Danvers, Mass.-based Abiomed 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; […]
FDA updates on Getinge/Datascope IABP recall, labels as Class I
The FDA today updated on Getinge (PINK:GETI B) subsidiaries Datascope and Maquet’s recall of its CS100i, CSO100 and CS300 intra-aortic balloon pumps, initially announced by the company in June, labeling it as a Class I recall. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use […]
Getinge’s Maquet, Datascope recall select IABPs over electrical issues
The FDA today released information on a select voluntary recall from Getinge‘s (PINK:GETI B) Datascope and Maquet of its System CS100, CS100i and CS300 intra-aortic balloon pumps over issues with potential electrical test failures. Datascope said they received a complaint in which the device failed to initiate therapy, resulting in a patient death. The complaint involved a […]
Datascope joins Maquet countersuit against Abiomed
Getinge‘s (PINK:GETI B) Datascope said today it is filing a motion to join fellow Getinge company Maquet‘s patent infringement case against Abiomed (NSDQ:ABMD). The Wayne, N.J.-based company said it is asserting counterclaims which allege that Abiomed engaged in false advertising to promote that its Impella device was superior to Datascope’s intra-aortic balloon pumps. Datascope said that, […]
Maquet warns on venting battery issues with Cardiosave balloon pumps
Getinge‘s (PINK:GETI B) medical subsidiary Maquet Cardiovascular recently issued an urgent product recall notice for its Cardiosave intra-aortic balloon pump over issues with its lithium ion batteries sparking or smoking after being dropped. In an urgent product recall notice, the company said it has received 3 reported occurrences of the batteries venting when dropped, creating the potential […]
