Medtronic device recalls updated to Class I
FDA updates Medtronic medical device recalls to Class I; warning letter sent to company for quality system failures - 9/13/06
The U.S. Food and Drug Administration (FDA) has sent a warning letter to Medtronic, Inc. stating its production practices to produce two medical devices do not meet federal quality standards. Dated August 29, 2006, the letter gives Medtronic 15 business days to file a correction plan with the FDA for its Fridley, MN, manufacturing facility outside Minneapolis.
The Fridley plant produces an implantable drug pump catheter that was pulled from the U.S. market in July, 2006 after the company received 22 reports of catheter tips dislodging in the spines of patients implanted with the devices. On Friday, September 8, the FDA upgraded the recall to a Class I, its most serious recall classification for medical devices.
A Class I recall is issued when a product is considered to have a high probability of causing personal injury or death to a consumer. The catheter tip is made of platinum-iridium and may be dislodged by the guide wire during implantation. Dislodgement could raise the risk of infection or other serious health problems in patients implanted with the devices.
The Medtronic recall involves the following medical devices that have not yet been implanted:
- Medtronic Model 8731 intrathecal tip catheters, made on or before August 2004
- Medtronic Model 8598 intrathecal catheter distal revision kit, made on or before August 2004
Implanted devices have not been recalled at this time. According to the "Dear Doctor" letter issued by Medtronic, Inc. in July, most patients with dislodged catheter tips had them remaining in the intrathecal space. Patients who reported adverse incidents with Medtronic catheters complained of post-operative leg pain and chronic back pain.
Concerned consumers who may be experiencing pain should report problems with implanted devices to the FDA Medwatch program:
Phone: 1-800-FDA-1088
Fax: 1-800-0178
Mail:
MedWatch
HF-2, FDA
5600 Fishers Lane
Rockville, MD 20852-9787
Sources: "FDA Sends warning letter to Medtronic," Memphis Business Journal, September 12, 2006; Jim McCartney, "Medtronic says it will fix drug-pump catheter flaws," St. Paul Pioneer Press, September 13, 2006; "Dear Healthcare Provider Letter," Medtronic, July 2006.
Product Liability
Defective or deficient consumer products that cause injuries to consumers can be the subjects of product liability lawsuits brought to trial by a personal injury lawyer. Frequently recalled products include cars, pharmaceutical and over-the-counter drugs, children’s toys, defective articles of clothing, and other common household products.
Medical Device Injuries
According to the Institute of Medicine, over a million Americans are severely injured each year by events involving medical devices; in 2002 alone, the US. Food and Drug Administration received more than 111,000 reports of adverse events involving medical devices (U.S. FDA Consumer Magazine, July-August 2003). If you have been injured while a medical device was deployed during your medical treatment, you should consider consulting with a NC medical device liability attorney who can advise you about the possible merits of your case.
