Datascope Corp. recalls Battery Charging Station; Model: 0998-00-0802;
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in…
Read the official notice →- Date
- 2026-03-25
- Country
- United States
- Brand
- Datascope
- Product
- Battery Charging Station; Model: 0998-00-0802;
- Classification
- Class III
- Units
- Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Datascope recalls
- 2026-03-11
USDatascope Corp. recalls CS300 IABP. Software Version CS300 IABP C.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
FDA · DeviceDatascope Corp.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →- 2025-12-24
- US
Datascope Corp. recalls Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
FDA · DeviceDatascope Corp.Domestic: Nationwide distribution. International: Albania, Algeria, Angola,…Official notice → - 2025-12-17
- US
Datascope Corp. recalls Cardiosave Rescue. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
FDA · DeviceDatascope Corp.Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola,…Official notice → - 2024-11-13
- US
Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
There is discrepant labeling on the inner and outer packaging of the device.
FDA · DeviceDatascope Corp.International distribution to the countries of Germany, Spain , Finland, Great…Official notice → - 2024-10-02
- US
Datascope Corp. recalls CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and…
FDA · DeviceDatascope Corp.International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA…Official notice → - US
Datascope Corp. recalls CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and…
FDA · DeviceDatascope Corp.International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA…Official notice →
Other drugs & medical recalls in the United States
- 2026-04-01
- US
- US
- US
- 2026-03-25
- US
Hologic, Inc. recalls Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Due to product exhibiting potential to generate either invalid or false negative results.
FDA · DeviceHologic, Inc.U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR,…Official notice → - US
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The…
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
FDA · DeviceDiagnostica Stago, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Singapore,…Official notice → - US
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
FDA · DeviceConvaTec, IncWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →