Cardiosave IABPs are used to inflate and deflate intra-aortic balloons. If they become unseated from the hospital cart, they can shut down without warning.
The FDA is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts.
The Cardiosave IABP may stop unexpectedly due to a high priority Gas Gain or Gas Loss alarm. The alarm will interrupt therapy and require user intervention to correct and restart.
New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg s are incorrectly labeled and contain Digoxin Tablets USP,
Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops).
The Cardiosave IABP may stop unexpectedly when internal temperatures exceed 176 degrees Fahrenheit.
On July 1, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: i.The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of
Hamilton Medical Inc. recalls HAMILTON-C1, C2, C3, T1 Ventilators for software issues that may cause ventilators to stop without notice after approximately 91 days of cumulative use.
Tesuque, NM, Dr. Berne’s Whole Health Products is voluntarily recalling all lots of MSM DROPS 5%,15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution to the consumer level.
Inmar Supply Chain Solutions, LLC (“Inmar”), is voluntarily recalling FDA regulated products* contained in pallets stored in Inmar’s Arlington, Texas facility between May 1, 2022, and June 30, 2023, the (“FDA Recalled Products”). The FDA Recalled Products were stored in this facility during a time
Contaminants exceed acceptable levels if used by pediatric patients for more than 30 days.
UV wands may cause injury to the skin, eyes, or both after a few seconds of use.
Abiomed recalls labeling for the Impella RP Flex with SmartAssist. The pump supports circulation of blood to the right heart and may cause blood clots.
Datascope/Maquet/Getinge recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA failures affecting the ability to charge the batteries
Philips Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators provide breathing support, but dust and dirt in the air path may impact air flow to patients.
Universal Meditech, Inc has notified FDA that it has stopped all operations. Their tests should not be used.
2023 Medical Device Recalls
Datascope/Maquet/Getinge recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for unexpected electrical shutdowns.
Drägerwerk AG & Co. KGaA initiated a voluntary recall notification for Dräger Carina Sub-Acute Care Ventilators to address possible contamination of the breathing gas with 1,3-Dichloropropan-2-ol, a constituent of the PE-PUR foam used for sound insulation. To date, Dräger’s market surveillance act
Software upgrades to the SIGMA Spectrum and Spectrum IQ infusion pumps are leading to an increase in false alarms for upstream occlusion.