Medtronic Recalls Insulin DeviceMay 19, 2004 | Star Tribune Medtronic Inc. said Tuesday it is recalling a portable insulin infusion device because of malfunctions that have sent some diabetics to the hospital.
The company's action was voluntary, but the Food and Drug Administration underscored the seriousness of the situation by classifying the move as a Class 1 recall, meaning there is "a reasonable probability that the use of the product will cause serious adverse health consequences or death."
The device, called a Quick-set Plus infusion set, has been on the market since November 2003. It pumps insulin into the body, eliminating the need for frequent injections. Medtronic said it first became aware of problems with some of the tubing for the device, which must be replaced every two to three days, early this year.
An adhesive problem with the tubing caused the needle to sometimes fall out of patients using it, stopping the flow of insulin.
Company spokesman Bob Hanvik said he didn't know how many people had been forced to the hospital by the malfunctioning device, which is made by Medtronic's Minimed subsidiary. Hanvik said there were no reported deaths.
About 160,000 to 200,000 units of the replaceable tubing remain in use. Patients are being offered replacement tubes along with free shipping.
Hanvik said the recall would have little financial meaning for Fridley-based Medtronic, and stock investors seemed to agree with that view late Tuesday. The news came out after the stock market closed, but Medtronic shares were down only 10 cents in after-hours trading.
The news is a public relations blow for the company, however, in that it has been a leader in the insulin pump market and this recall comes just a month after the company issued a voluntary recall of two implantable heart defibrillator models.
The recalled defibrillators, a version of the Micro Jewell II, might take too long to emit a charge to the heart, Medtronic said in April. The company said one serious injury and four deaths may have been related to the defibrillators, which remain in about 1,800 people worldwide but are no longer being sold.