Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34,…
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Read the official notice →- Date
- 2021-10-13
- Country
- United States
- Brand
- Datascope
- Product
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34,…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-01-25
USDatascope 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,…
The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
FDA · DeviceDatascope Corp.Worldwide Distribution - US Nationwide and the countries of Albania, Angola,…Official notice →- 2022-11-02
- US
Datascope Corporation recalls LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy.…
FDA · DeviceDatascope CorporationNo US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile,…Official notice → - 2022-09-14
- US
Datascope Corporation recalls MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Certain lots containing undersized dilator.
FDA · DeviceDatascope CorporationAwaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech…Official notice → - 2021-12-22
- US
Datascope Corp. recalls Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83,…
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic…
- 2021-10-27
- US
Datascope Corp. recalls Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below…
A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to…
FDA · DeviceDatascope Corp.Worldwide distribution. US nationwide, Australia, Brazil, Bahrain, Belgium,…Official notice → - 2021-10-06
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34,…
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs…
FDA · DeviceDatascope Corp.Nationwide domestic distribution. Foreign distribution worldwide.Official notice →
Other drugs & medical recalls in the United States
- 2021-10-20
- US
Eli Lilly & Company recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed…
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
FDA · DrugEli Lilly & CompanyNationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, MexicoOfficial notice → - US
- US
- 2021-10-13
- US
DePuy Orthopaedics, Inc. recalls ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
FDA · DeviceDePuy Orthopaedics, Inc.US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA,…Official notice → - US
Angiodynamics, Inc. recalls AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID…
Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
FDA · DeviceAngiodynamics, Inc.Internationally distribution to the countries of Australia, Germany, Denmark,…Official notice → - US
Innovative Orthopedic Technologies, LLC recalls ARCH Leg Positioning System
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
FDA · DeviceInnovative Orthopedic Technologies, LLCU.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and…Official notice →