Medtronic’s implantable SynchroMed II drug pumps were issued a Class 1 recall by the Food and Drug Administration (FDA).
About the Medtronic Pain Pump Recall
The Medtronic company declared an official, voluntary recall of their product this past October 2019. Various users of the drug pumps suffered with issues from permanently stalled and defective pumps. This was a crucial matter since stalled pumps could lead to major dilemmas among patients such as drug withdrawal, injury, surgery, or even death.
An underlying error of the pumps lied within a manufacturing problem of an irrelevant piece being lodged in the motor assembly. This error was quickly confirmed as 5 recent cases of foreign pieces stalling motor assemblies were reported by the FDA.
No deaths have been recorded as of yet.
Description of the Pain Pump Recall
- The drug pumps official use is to administer prescription drugs into the body through use of a catheter to the patient’s spinal fluid
- The drugs treat chronic or various other types of pains. Thus, motor stalls prevent the drugs from helping the patients and often lead to pain.
- The recall covers 11,299 SynchroMed II Models 8637-20 and 8637-40 manufactured from May 4, 2018 to April 5, 2019
- This amount includes 7,317 pumps sold within the U.S.
Contact an Experienced Defective Medical Device Attorney
If you or a loved one have been injured by a dangerous SynchroMed pain pump, contact Thomas J. Henry. For more than a decade, Medtronic’s SynchroMed II pain pump has been subjected to multiple recalls and the company has been under scrutiny for failing to address important safety issues. Complications from a malfunctioning pain pump can include respiratory distress, overdose, withdrawals, coma, and in some cases death. You may be entitled to compensation if you were harmed by a defective medical device like the SynchroMed II pain pump. Contact us today for a free legal consultation and speak to one of our experienced medical device attorneys — available 24/7, nights and weekends.