Maquet Datascope Corp./Getinge Group Recalls the CARDIOSAVE Hybrid Intra-aortic Balloon Pump due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product(s): CARDIOSAVE Hybrid Intra-aortic Balloon Pump (IABP)
- Part Numbers: 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
- Lot Numbers: All lots
- Manufacturing Dates: December 12, 2011 to April 25, 2018
- Distribution Dates: March 6, 2012 to April 26, 2018
- Devices Recalled in the U.S.: 2826 units nationwide
The CARDIOSAVE Hybrid Intra-aortic Balloon Pump (IABPs) 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.
Reason for Recall
Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.
Who May be Affected
- Hospitals and health care professionals using a Maquet Datascope Corp.'s CARDIOSAVE Hybrid IABP.
- Patients receiving circulatory support with a Maquet Datascope Corp.'s CARDIOSAVE Hybrid IABP.
What to Do
On May 4, 2018, Maquet Datascope Corp. issued an Urgent Medical Device Correction letter to all device consignees. Pursuant to the caution section of the IABP Operating/User Instructions, the letter instructed users to:
- Never place fluids on top of the unit;
- Ensure that the saline container and tubing do not hang directly over the IABP; and
- 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 5 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.
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.
Customer in the U.S. looking for 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 8:00 am and 6:00 pm Eastern Standard Time.
Date Recall Initiated
May 3, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.