June 6, 2018 — Maquet Datascope Corp. said it is recalling the CardioSave Hybrid Intra-aortic Balloon Pump (IABP) due to fluid ingress that may affect device operation, interrupt or delay therapy.
The U.S. Food and Drug Administration (FDA) issued a safety alert today that stated a design issue in the IABP can allow fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards. The FDA said this can lead to device malfunction like sudden stops, which can cause a delay or interruption in therapy. The FDA said device failure may result in immediate and serious adverse health consequences, including death.
The recall includes CardioSave Hybrid IABP part numbers: 0998-00-0800-XX, 0998-UC-0800-XX and cart 0997-00-1179 (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75). The FDA said all lots are affected by this recall.
The manufacturing dates include Dec 12, 2011 through April 25, 2018. The distribution dates were between March 6, 2012 to April 26, 2018.
The CardioSave IABP is a cardiac assist device used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure, the FDA stated.
Recommendations for Users:
• Never place fluids on top of the unit
• Ensure that the saline container and tubing do not hang directly over the IABP
• In case of accidental spillage, to wipe clean immediately and have the unit serviced to ensure no hazard exists.
• In case of an interruption in therapy, the letter instructed users to:
• Transfer the patient to an alternative IABP
• If an alternative IABP is unavailable, manually inflate the IAB with air or helium and immediately aspirate repeat every five minutes until either an alternate IABP is available or alternatively (i.e., if an alternative IABP is not available in a reasonable amount of time) the intra-aortic balloon catheter should be removed from the patient.
The FDA said affected customers will be contacted by Maquet Datascope Corp. to schedule on-site service of the IABP by a Maquet Datascope Corp. sales or service representative. The company anticipates having the protective top cover available by late June 2018.
U.S. customers wanting more information about this recall can contact Maquet Datascope Corp.’s Technical Support Department at 1-888-627-8383 (press option 3), Monday through Friday, between 8 a.m. and 6 p.m. Eastern Standard Time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.