FDA Class I recall: Medtronic Perfusion Systems’ Bio-Console 560 Extracorporeal Blood Pumping Console

April 21, 2021

Medtronic is recalling the Bio-Console 560 Extracorporeal Blood Pumping Console due to reports of electrical failure causing the device to stop, reported the U.S. Food and Drug Administration (FDA). The FDA has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.

Other issues observed by users include the interface going blank, smoke coming from the device and a burning odor during use. In cases where the pump stopped or the interface went blank, users had to operate the pump using a hand crank until the device restarted or could be replaced by a backup unit. If the pump stops, patients could experience:

  • Insufficient blood flow potentially leading to organ dysfunction
  • Blood clots potentially leading to low blood pressure
  • Reversible or irreversible neurological dysfunction
  • Death

There have been nine complaints reported about this device issue, including three injuries. No deaths have been reported.

Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (Bio-Console 560) includes:

  • Models: 560BC, 560BCS, 560BC1, 560BCS1, R560BCS1
  • Serial Numbers: Please See Links Below.
  • Distribution Dates: April 1, 2019 to February 12, 2021
  • Devices Recalled in the U.S.: 93
  • Date Initiated by Firm: March 3, 2021

The Bio-Console 560 Extracorporeal Blood Pumping Console is used to pump and return blood to a person during cardiopulmonary bypass, a procedure that temporarily takes over the function of the heart and lungs during surgery. The cardiopulmonary bypass procedure provides both circulatory and breathing support to a person whose heart and lungs are too weak to pump enough blood to the rest of the body. The Bio-Console 560 can pump blood for up to six hours each time used.

On March 3, 2021, Medtronic sent an Urgent Medical Device Correction letter to all affected distributors and customers. The letter requested that customers take the following actions:

  • Review the Customer Notification Detail Report sent with the letter to identify potentially affected devices.
  • Use unaffected Bio-Console 560 devices, if available, until correction has been completed for affected Bio-Console 560 devices.
  • Complete a Customer Confirmation Certificate (also attached to the letter) and scan or email to [email protected].
  • Contact a Medtronic Field Service Representative to schedule the service event to correct any affected Bio-Console 560 devices and reference Technical Service Update (TSU) “MOD0204” when scheduling.

Customers should contact their Medtronic Sales or Service Representative with questions.

FDA has the recall.