Maquet cardiosave recall

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August undefined, 2024

Getinge/Datascope/Maquet is recalling these products due to complaints of fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy. There has been one death and 71 complaints reported about this device issue. See more The CardioSave Hybrid/Rescue Intra-Aortic Balloon Pumps (IABP) are cardiac (heart) assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary … See more On November 15, 2024, Getinge/Datascope/Maquet sent an Urgent Medical Device Correction Letter to customers instructing them to: 1. Immediately examine … See more WebDec 16, 2024 · FDA Announces Recall of Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue IABPs December 16, 2024—FDA advised that the Getinge Group has recalled the Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs; …

Cardiosave Trainer User Manual

WebMaquet CARDIOSAVE ® Hybrid Intra ... You may have previously received the Maquet Urgent Product Recall notification, dated December 2015, regarding a potential issue relating to the scroll compressor of your CARDIOSAVE Hybrid and/or CARDIOSAVE Rescue IntraAortic Balloon Pumps (IABPs), which will be collectively referred to in this … WebDec 16, 2024 · FDA Announces Recall of Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue IABPs December 16, 2024—FDA advised that the Getinge Group has recalled the Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs; Getinge/Maquet/Datascope) because of reports of fluid leaks. mahesh\u0027s kitchen menu

FDA announces serious device recall AHA News

WebGetinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp.,... WebJun 11, 2024 · On June 6, Maquet Datascope Corp. issued a Class I recall for the CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), a cardiac assist device used for patients undergoing cardiac and non-cardiac surgery and patients with acute coronary syndrome or complications from heart failure, due to a design issue that allows fluid … WebJun 7, 2024 · The US Food and Drug Administration (FDA) has alerted users of Datascope Corp/MAQUET’s Cardiosave hybrid intra-aortic balloon pump (IABP) to a “design issue” that enables fluids to leak into the device, classifying a recent field corrective action by the company as a Class I recall. “The fluid can cause corrosion of internal components ... mahesh uberoi

Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) …

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

WebDec 16, 2024 · Fluid leaks causing unexpected pump shutdown or the inability to initiate therapy have prompted the recall of Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs). At the time the recall was issued, the U.S. Food and Drug Administration (FDA) had received 71 complaints. One death was reported. These … WebOct 29, 2024 · Datascope/Getinge/Maquet is recalling 137 substandard battery packs for the CardioSave Hybrid/Rescue Intra-Aortic Balloon Pump, which may cause the cardiac assist device to stop working when operated by battery only. Customers should examine their … maheshum maruthiyum release dateWebDec 22, 2024 · (UPDATED) The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been placed under recall by the manufacturer (Getinge/Datascope/Maquet) following reports of fluid leaks, the US Food and Drug Administration announced last Thursday. The agency deemed the action a Class I … mahesh uncle

"WebDec 22, 2024 · (UPDATED) The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been placed under recall by the manufacturer (Getinge/Datascope/Maquet) following reports of fluid leaks, the US Food and Drug … " - Maquet cardiosave recall

Maquet cardiosave recall

Maquet Cardiosave Rescue - IABP - Featuring …

WebDec 17, 2024 · So far, 4,338 devices have been recalled in the U.S., with one death and 71 complaints related to the device issue, which the FDA confirmed is fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy, the regulatory body said. WebJul 24, 2024 · Medical device models being affected include Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP, and CS100/100i IABP. A total of 22,853 devices are covered by the recall. CS300 Intra-Aortic Balloon Pump. Source: Maquet/Datascope

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WebJul 24, 2024 · Getinge is recalling numerous Maquet/Datascope intra-aortic balloon pumps (IABPs) due to potential battery failure during use that can lead to unexpected stopping and shortened run times. Maquet/Datascope has received reports of five patient deaths … WebNov 15, 2024 · Datascope/Getinge Technical Support. 888-943-8872. Manufacturer Reason. for Recall. Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

WebDec 16, 2024 · Recalled Product Product Names: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Model Numbers: See Recall Database Entry Manufacturing... WebJul 11, 2024 · Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794. Code Information. Lot 70131093; UDI 04037691741543. Recalling Firm/. Manufacturer. Maquet Cardiovascular Us Sales, …

WebCARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP. Model / Serial PART NUMBER: 0146-00-0097 DISTRIBUTION DATE: All Li-Ion Batteries Distributed from December 12, 2011 to November 9, 2016 ... Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their … WebMar 7, 2024 · The recall notice affects lithium-ion batteries used with its Cardiosave hybrid IABP and its Cardiosave rescue IABP with part number 0146-00-0097, distributed between Dec. 12, 2011 and Nov. 9, 2016.

WebDevice Recall Maquet Model / Serial HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786 ...

WebSep 27, 2024 · The FDA announced that Getinge issued a voluntary recall of two intra-aortic balloon pumps due to interruption or inability to start therapy at high altitudes.The recall involves 5,223 Maquet ... mahesh\\u0027s kitchen sugar landWebDevice Recall Maquet Model / Serial HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786 ... Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Manufacturer Maquet … o365 l3 interview questions and answersWebDec 23, 2016 · Class 2 Device Recall Cardiosave. Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped. Maquet contacted their customers via letter on 12/23/16 and additional … mahesh uppalWebDec 16, 2024 · Recalled Product Product Names: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Model Numbers: See Recall Database Entry Manufacturing... maheshum maruthiyum reviewWebOct 29, 2024 · FDA announces serious device recall Oct 29, 2024 - 03:06 PM The Food and Drug Administration today announced a Class 1 recall of battery packs for an intra-aortic balloon pump used with patients undergoing surgery and to treat adults with acute coronary syndrome or heart failure complications. mahesh value products p ltdWebOct 29, 2024 · Recalled Product. Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs. Product Codes and Lot Numbers: See Recall Database Entry. Devices Recalled in the United States: 137 battery ... mahesh vandana lyricsWebDec 2, 2024 · On November 29, 2024, Getinge posted a notification letter on its website informing customers of a shortage of Maquet/Datascope IAB catheters, new Cardiosave IABP devices, and Cardiosave IABP... o365 information governance retention