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| FlexCath--Courtesy of Medtronic |
The FDA just labeled the recall of Medtronic's ($MDT) 10 French FlexCath Select Steerable Sheath as a class I recall. This means there is a reasonable probability that the device "will cause serious adverse health consequences or death."
The single-use device is used to percutaneously introduce a catheter into the vasculature and chambers of the heart. The device is not implanted in the body. The hemostasis valve on the sheath remains outside of the patient's body during use.
The FDA blamed the problem on conformance with its Good Manufacturing Practices regulations, saying "Medtronic received four (4) reports where clinicians observed debris appearing to originate from the hemostasis valve on the proximal end of Model 990065 FlexCath Select Steerable Sheath (10 Fr), outside of the patients' bodies. There have been no reports of patient injury or death associated with this issue, nor are any predicted."
This appears to be an instance of the most common complaint regarding devices used to introduce a catheter into the body: material separation. There have been 343 complaints of material separation regarding the class of devices, according to the FDA database of adverse events. Breakages are in second place with 233 complaints.
The recall notice also contains the affected lot numbers. Overall, 151 units of the FlexCath have been recalled, mostly in Europe, although four of the 151 units were recalled in the U.S. No affected product in the U.S. remains with customers, Medtronic says.
Medtronic sent a recall letter in February to alert customers of the risk of the device malfunctioning and telling them to return the affected models.
The recall is ongoing, and the new Class I designation adds urgency to the effort to take the faulty FlexCath's off of the market.
- here's the recall notice | more about the safety profile of catheter introducer's in general from the FDA
Editor's Note: This article has been updated with additional information from Medtronic.