Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 recallZ-0100-2019 · Maquet Datascope Corp - Cardiac Assist Division · initiated Sep 20, 2018
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Datascope Corp - Cardiac Assist Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-0100-2019
- Status
- Open, Classified
- Initiated by the company
- Sep 20, 2018
- Posted by the FDA
- Oct 27, 2018
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Product code
- DSP
- FDA submissions
- K181122
- Distribution
- US Nationwide; Internationally to 77 countries
Product description
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Code information (models, lots, serial numbers)
UDI - 10607567108407 All Serial Numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CARDIOSAVE RESCUE 0998-00-0800-83Datascope Corp. · System, Balloon, Intra-Aortic And Control26 recalls167 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 81055).
- Z-0099-2019 · Open, ClassifiedCardiosave Hybrid IABP, Part Number 0998-00-0800-53
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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