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U.S. Department of Health and Human Services

Class 1 Device Recall Cardiosave Hybrid IABP

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  Class 1 Device Recall Cardiosave Hybrid IABP see related information
Date Initiated by Firm September 20, 2018
Date Posted October 27, 2018
Recall Status1 Open3, Classified
Recall Number Z-0099-2019
Recall Event ID 81055
510(K)Number K181122  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Code Information UDI - 10607567108391 All Serial Numbers
Recalling Firm/
Manufacturer		 Maquet Datascope Corp - Cardiac Assist Division
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact
973-244-6138
Manufacturer Reason
for Recall		 There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
FDA Determined
Cause 2		 Device Design
Action On September 20, 2018, Maquet/Getinge issued a press release. On September 24, 2018 and on September 28, 2018, Maquet/Getinge issued URGENT MEDICAL DEVICE CORRECTION notices along with an Instructions for Use Addendum to customers. On October 23, 2018 a modified version of the Urgent Medical Device Correction Letter and response form was sent to 23 new U.S. consignees who received Cardiosave IABP devices after the ship-hold was released. The post ship-hold devices contain the IFU addendum. This modified version of the letter notifies customers of the altitude issue and the required software update. Maquet/Getinge is currently developing a software correction to address this issue. Customers are encouraged to use the following items as specified according to altitude levels: Sensation 34cc / 40cc (Balloon Name and Size) Sensation Plus 40cc / 50cc (Balloon Name and Size) Operating Altitude: -1250 feet to 3,200 feet (795 mmHg to 676 mmHg) (1060 hPa to 901 hPa) Mega 50cc (Balloon Name & Size) Operating Altitude: -1250 feet to 5000 feet (795 mmHg to 632 mmHg) (1060 hPa to 843 hPa) Mega 30cc / 40cc (Balloon Name & Size) Linear 25cc / 34cc / 40cc (Balloon Name & Size) Operating Altitude: -1250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1060 hPa to 644 hPa) For technical questions, please contact Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST
Distribution US Nationwide; Internationally to 77 countries
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = Datascope Corp.
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