The FDA has issued a recall for Medtronic drug pumps. The recall notice came Friday. The pumps involved are the Indura 1P Intrathecal Catheter, model 8709SC; Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. The pumps are used in patients who have spasticity related to cystic fibrosis, traumatic brain injury and multiple sclerosis and from chronic pain.
The FDA issued a Class I recall which means that there is a “reasonable probability” that the product may cause serious adverse health consequences or death. Improper connections between the implanted catheter and the pump cause the medications to leak. At least 25,000 of these pumps have been sold.