May 9, 2014 - Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System. The affected IABP's can be identified by part and serial number. November 5, 2018 — The U.S. Food and Drug Administration (FDA) is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP).

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Source Date Type Note 7/25/1983 Foreign Qualification 1/12/1984 Amendment ARTICLE II CAPITAL STOCK WAS: $60,000.00 = 6,000,000 @ $.01 REST OF CAPITAL IS: 12,000,000 @ $.01 REST OF PAR SHARES IS: 12,000,000 @ $.01 7/26/1989 Annual List List of Officers for 1989 to 1990 1/4/1990 Name History/Actual Datascope Corp. 1/30/1990 Application For Certificate Of Authority 2/7/1990 Merger CERTIFICATE OF MERGER MERGING THIS CORPORATION INTO: DATASCOPE CORP. (NEW YORK) NOT QUAL.

November 5, 2018 — The U.S. Food and Drug Administration (FDA) is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power. The company issued a letter to providers warning them about this issue Nov. IABPs are used on critically-ill patients in health care facilities, including during transport. The vendor said an interruption in treatment can result in serious patient injury or death. The Maquet/Datascope IABP is a cardiac assist device placed in the descending aorta, just distal to the left subclavian artery.

The device is an electromechanical system used to inflate and deflate intra-aortic balloons, which provides temporary support to the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Getinge manufactures the following Maquet/Datascope IABP devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. Since 2017, the FDA has received more than 75 medical device reports of Maquet/Datascope IABP devices shutting down while running on battery, leading to pump stop and loss of hemodynamic support. Five of these reports described three patient deaths, although the deaths cannot be definitively attributed to the device shutting down.

Other reports describe serious patient injury such as a sudden drop in blood pressure or the need for resuscitation. At least six reports indicated that there was no alarm warning before the device shutdown. The company said the onset of the shutdown as described in the reports ranges from immediately following disconnection of the IABP from AC power (electricity) to within the expected battery run time. In addition to device shutdown, there are reports describing several battery issues that could lead to patient harm, such as the device not charging the battery, the battery charge indicator not working properly or not showing the correct status of the battery charge, or the battery depleting sooner than expected. 'At this time, the root cause or incidence rate of these IABP devices shutting down while on batteries is not known. Although we are concerned about the device shutdown events associated with Maquet/Datascope IABPs, we recognize that these systems may be the best option for circulatory support for some patients. The FDA wants to ensure you are aware of these device failures that have been observed in patients treated with Maquet/Datascope IABPs and reported to the FDA,' the company stated it is letter.