Medtronic this week issues an urgent field safety notice for some of its Prevail Paclitaxel-coated PTCA balloon catheters.
The Fridley, Minnesota-based company issued the warning due to the potential for an incorrect compliance chart attached to the catheter hoop. The balloon size on the compliance chart differed from the balloon size detailed on the packaging, according to the warning letter.
Use of the incorrect chart could result in intimal dissection, intimal dissection leading to perforation or re-occlusion.
Medtronic has received one complaint associated with this issue and no reports of patient injury.
To mitigate risk, Medtronic recommends reviewing the inventory for the Prevail lot 0010735590 and quarantining all unused, listed products in your inventory. The company recommends returning unused products.
Medtronic launched the Prevail catheter in July 2021. It is indicated for percutaneous coronary intervention procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease. During the procedure, the balloon inflates within the artery as the drug is delivered to the arterial tissue where it can be absorbed. The Prevail drug-coated balloon uses rapid absorption drug paclitaxel to treat de novo lesions, small vessel disease and in-stent restenosis.
Affected product numbers include:
PRV020010RX, PRV020015RX, PRV020020RX, PRV020025RX, PRV020030RX, PRV022510RX, PRV022515RX, PRV022520RX, PRV022525RX, PRV025010RX, PRV025015RX, PRV025020RX, PRV025025RX, PRV025030RX, PRV027510RX, PRV027515RX, PRV027520RX, PRV027525RX, PRV030010RX, PRV030015RX, PRV030020RX, PRV030025RX, PRV030030RX, PRV035010RX, PRV035015RX, PRV035020RX, PRV035025RX, PRV035030RX, PRV040010RX, PRV040015RX, PRV040020RX, PRV040025RX and PRV040030RX.
Lot numbers can be found on the warning letter here.
