2024 Maquet cardiosave recall

Maquet cardiosave recall

Author: qyqf

August undefined, 2024

WebMAQUET CARDIOSAVE hybrid and MAQUET CARDIOSAVE rescue Product Code/Part Number: 0998-XX-0800-XX Distributed Affected Lot Number: All Distribution Dates: Since March 6, 2012 ... This voluntary recall only affects the products listed on page 1; no other products are affected WebWeb getinge group maquet cardiosave iabp quick reference manual (41 pages) iab insertion, iabp operation. Cardiosave hybrid retains the familiar look of datascope pumps, while offering an improved user interface and improved algorithms and pneumatics to allow for enhanced. ... Recall Datascope/Getinge Cardiosave Hybrid, Cardiosave Rescue, …

Cardiosave Hybrid and Rescue IABPs Recalled for Fluid Leaks

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 Administration announced last Thursday. The agency deemed the action a Class I … WebDec 21, 2015 · U kunt hier een specifiek type publicatie kiezen, zoals brochures of jaarverslagen. storm and otis

Class 2 Device Recall Cardiosave Rescue IntraAortic …

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 … 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 … WebSep 8, 2024 · Recall Status 1: Open 3, Classified: Recall Number: Z-0076-2024: Recall Event ID: 88651: 510(K)Number: K181122 Product Classification: System, balloon, intra-aortic and control - Product Code DSP:... rosey souse

Device Recall Maquet - International Consortium of Investigative ...

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. 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 ... rosey skin color rosey skin care

"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. " - Maquet cardiosave recall

Maquet cardiosave recall

Getinge Issues Worldwide Voluntary Correction of Maquet…

WebOct 29, 2024 · Reason for Recall Datascope/Getinge/Maquet is recalling this product due to the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting performance... 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

Did you know?

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 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...

WebDec 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 … 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 ...

WebSep 8, 2024 · for Recall: The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery... WebDatascope Cs100 Service Manual iforex indicators com. Getinge s Maquet Datascope recall select IABPs over. China Bionet Cardiocare 2000 EKG Cable 10lead 15pins. Hospital Furniture Manufacturing Companies Hospital. Public tenders for Medical equipment in United States. Datascope MAQUET Intra Aortic Balloon Pump Recall ? Daily.

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 …

WebMaquet Cardiovascular Us Sales, Llc QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Res... 1 11/28/2024 Maquet Cardiovascular Us Sales, Llc Cardiosave Hybrid IABP, Part Number 0998-00-0800-53: 1 10/27/2024 Maquet Datascope Corp - Cardiac Assist Division stor mand lyuricsWebDec 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 … storm and park group llcWebMar 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. stormandpartners.comWebOct 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 … storm and park groupWebNov 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. storm and panthersWebMaquet Cardiosave Rescue Features. The Maquet CARDIOSAVE Rescue represents a giant leap forward in functionality and versatility while continuing to deliver the performance and intuitiveness of the Datascope … roseys mexican mandarin flWebMay 16, 2024 · Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP) Due to Potential Battery Failure ... Reason for Recall. Maquet/Datascope is recalling all IABPs due to reports of the IABP batteries failing to hold a charge, stopping unexpectedly, and having a shortened run … rosey singer