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Medtronic warns on Prevail Paclitaxel-coated PTCA balloon catheter

September 7, 2022 By Danielle Kirsh

Medtronic-logoMedtronic 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.

Filed Under: Catheters Tagged With: medtronic

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

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