Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34…
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
Read the official notice →- Date
- 2023-07-26
- Country
- United States
- Brand
- Datascope
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34…
- Classification
- Class I
- Units
- Worldwide Distribution- US (Nationwide) and OUS (foreign) countries of:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2023-09-06
USDatascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33,…
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33,…
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully…
- 2023-08-02
- US
Datascope Corp. recalls LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product…
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending…
FDA · DeviceDatascope Corp.Domestic distribution nationwide. International distribution worldwide.Official notice → - 2023-07-26
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34…
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the…
FDA · DeviceDatascope Corp.Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of:…Official notice → - 2023-06-21
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
- 2023-05-03
- US
Datascope Corp. recalls MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
Other drugs & medical recalls in the United States
- 2023-07-26
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution. There was government distribution but no military…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F;…
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide Distribution: US (Nationwide) and OUS (foreign) United Arab…Official notice → - US
DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct…
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
FDA · DeviceDiaSorin Molecular LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34…
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the…
FDA · DeviceDatascope Corp.Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of:…Official notice → - US
Bryan Medical Inc recalls Aeris Balloon Dilation Catheter
Devices were mislabeled.
FDA · DeviceBryan Medical IncUS Nationwide distribution in the states of GA, NY, & PA.Official notice → - US
Cardinal Health 200, LLC recalls NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.