Fridley-based Medtronic is recalling an implantable drug pump that the company says is responsible for the deaths of 14 patients, the Star Tribune reports.
The company announced the recall Thursday, a day after the device was subject to recalls from Food and Drug Administration, the paper reports.
The Strib says the company had warned patients about problems with the pump on June 1, but the FDA made it a Class I recall, meaning “there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the FDA.
The SynchroMed pump is used to deliver drugs directly to the cerebral spinal fluid. Medtronic spokeswoman Donna Marquard tells the paper the SynchroMed pump “continues to demonstrate strong overall reliability, and Medtronic remains confident in its ability to deliver safe and effective therapy for those who need it.”