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.
- Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (Bio-Console 560)
- 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.
Reason for Recall
Medtronic is recalling the Bio-Console 560 Extracorporeal Blood Pumping Console due to reports of electrical failure causing the device to stop. 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
There have been nine complaints reported about this device issue, including three injuries. No deaths have been reported.
Who May be Affected
- Health care providers using the affected Bio-Console 560 Extracorporeal Blood Pumping Console
- Patients who require care using the affected Bio-Console 560 Extracorporeal Blood Pumping Console
What to Do
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 RS.CFQFCA@medtronic.com.
- 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.
Full List of Affected Devices
- Please See Link Below
Bio-Console 560 Console Affected Model Numbers and Serial Numbers
Models: 560BC, 560BCS, 560BC1, 560BCS1, R560BCS1
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.