Datascope Corp. recalls Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45…
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the…
Read the official notice →- Date
- 2023-03-15
- Country
- United States
- Brand
- Datascope
- Product
- Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45…
- Classification
- Class I
- Units
- Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-03-29
USDatascope 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 → - US
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of…
- US
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers…
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the…
FDA · DeviceDatascope Corp.Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA,…Official notice → - 2023-01-25
- 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,…
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 →
Other drugs & medical recalls in the United States
- 2023-03-15
- US
LetsGetChecked Inc. recalls LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and…
Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned…
- US
Linet Spol. S.r.o. recalls Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.
FDA · DeviceLinet Spol. S.r.o.US Distribution was made to AL, CA, FL, IA, KY, LA, MN, NV, NC, OK, TX, VA,…Official notice → - US
DiaSorin Molecular LLC recalls Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
FDA · DeviceDiaSorin Molecular LLCUS Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL,…Official notice → - US
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers…
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the…
FDA · DeviceDatascope Corp.Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA,…Official notice → - US
Pharmedica USA, LLC recalls Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034…
CGMP Deviations
FDA · DrugPharmedica USA, LLCNationwide in the USA and Worldwide through e-commerce and trade showsOfficial notice → - US
Pharmedica USA, LLC recalls Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034…
Non-Sterility
FDA · DrugPharmedica USA, LLCNationwide in the USA and Worldwide through e-commerce and trade showsOfficial notice →