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…
Read the official notice →- Date
- 2021-10-27
- Country
- United States
- Brand
- Datascope
- Product
- Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below…
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide, Australia, Brazil, Bahrain, Belgium,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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…
- 2021-10-13
- 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 Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
- 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
- 2021-10-27
- US
Fort Defiance Industries, LLC recalls P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
FDA · DeviceFort Defiance Industries, LLCDistributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally…Official notice → - US
Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the…
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
FDA · DeviceOrtho Clinical Diagnostics IncWorldwide Distribution: US (Nationwide) in states of: AL, AR, AZ, CA, CO, DC,…Official notice → - US
Smiths Medical ASD Inc. recalls CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L…
Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump…
FDA · DeviceSmiths Medical ASD Inc.Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT,…Official notice → - US
Lupin Pharmaceuticals Inc. recalls Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
- US
Dr. Reddy's Laboratories, Inc. recalls Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle…
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
- US
Teva Pharmaceuticals USA recalls AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC…
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol