A Medical Device Daily
Following receipt of a warning letter from the FDA, Medtronic (Minneapolis), said this week that it will develop a plan to correct quality-system problems with two of its drug-pump catheters.
In July, Medtronic took 934 drug-pump catheters off the market after receiving 22 reports of catheter tips dislodging in patients' spines. Federal regulators recently designated the action a Class I recall because the dislodgement of the tip could result in the risk of infection or other serious health problems. In one case, the tip detached in a patient's leg, the FDA said.
In a letter dated Aug. 29, the agency said that the company repeatedly had failed to comply with manufacturing standards, that conclusion based on inspections conducted in May and June at the company's Sullivan Lake facility in Fridley.
Medtronic sent the agency a plan to correct some of the manufacturing flaws during July, but it has not followed up with additional information, the FDA said.
The devices consist of a pump that is placed in the abdomen, and a connected catheter that is inserted into the spinal canal and tunneled under the skin, according to the company website.
Medtronic recalled all unused Model 8731 intrathecal tip catheters and a related Model 8598 kit made on or before August 2004. Implanted devices were not included in the recall. It sent a letter to doctors, saying that there were 22 reports of the platinum-iridium tips on its catheter dislodging inside patients.
Medtronic said it has already addressed some of the issues and expects to provide a plan for others within the FDA's required 15-day period provided to the company for making a response.