Medtronic Recalling Three Million Insulin Infusion Sets; Units May Deliver Wrong Amounts of Insulin
Medtronic Inc., a leading manufacturer of medical devices, is recalling about three million of its insulin infusion sets because the units may deliver incorrect amounts of insulin to patients, possibly causing severe injury or death, according to a report today in The Wall Street Journal.
A problem in how about 60,000 of the units vent air pressure may be causing the dosage problems, company officials said. The sets are used with Medtronic MiniMed insulin pump and consist of thin plastic tubes used to deliver insulin to diabetic patients.
Patients who use the recalled insulin infusion sets have been notified of the recall by mail, officials said. Also, one million replacement sets have been sent to users. The replacement sets give users a one-month supply of infusion tubes to use in lieu of the potentially defective sets being recalled.
In the meantime, Medtronic said patients should immediately stop using “Lot 8” Quick-set infusion sets, most of which were sold in the United States.
In June, Medtronic was warned by the Food and Drug Administration about the company’s failure to adequately report problems with the company’s Synchromed drug pump and the MiniMed pump. The FDA said Medtronic waited nearly two years after problems with the Synchromed pumps surfaced to recall the products. Also, the company was accused of failing to properly follow up on consumer complaints received about the MiniMed insulin pump, which is used in conjunction with the insulin infusion sets being recalled today.
Also last month, Medtronic announced the recall of about 21,000 pacemakers due to problems with the batteries that might cause the life-saving devices to malfunction.
The company’s Sprint Fidelis heart defibrillator leads have been blamed for causing scores of patient deaths and injuries when they failed to work properly.
Related posts:
- Millions of Infusion Set Needles Recalled More than two million infusion set needles are included in...
- Medtronic Issues Class I Recall of Sutureless Catheter and IsoMed Infusion Pump Medtronic Inc. has issued an urgent recall of its Sutureless...
- Medtronic Warns About Faulty Batteries in Implanted Heart Devices Medtronic Inc., a worldwide leader in heart defibrillators, pacemakers, and...
- 1.6 Million Little Tikes Workshop Sets and Trucks Recalled due to Choking Hazard About 1.6 million Little Tikes Workshops Sets and Trucks are...
- Medtronic Paradigm Quick-Set Infusion Sets Audience: Diabetes healthcare professionals, patients Medtronic, Inc. and FDA notified...
