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.
Read the official notice →- Date
- 2023-06-21
- Country
- United States
- Brand
- Datascope
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
- Classification
- Class III
- Units
- International distribution in the country of Germany.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-08-02
USDatascope 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…
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.
FDA · DeviceDatascope Corp.Worldwide Distribution- US (Nationwide) and OUS (foreign) countries of:…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 → - 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.
- 2023-03-29
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to…
- 2023-03-15
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35,…
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
FDA · DeviceDatascope Corp.Nationwide US distribution. Worldwide international distribution.Official notice →
Other drugs & medical recalls in the United States
- 2023-06-21
- US
Vyaire Medical recalls bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application…
- US
Howmedica Osteonics Corp. recalls Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of Ireland.Official notice → - US
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice → - US
Ossur H / F recalls Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption…
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the…
FDA · DeviceOssur H / FUS: SC, FL,NM, PA, VA, CA, TX, MT, UT, OH, NV, KS, MI, GA, IA, WA, TN, AZ, MN,…Official notice → - US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
FDA · DeviceRemote Diagnostic Technologies Ltd.US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.Official notice → - US
New Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
The threads on posts stripping out when tensioned during application process.
FDA · DeviceNew Standard Device IncU.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.Official notice →