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OPN NC

SIS Medical AG · Model 150-015-004 · UDI-DI 07640142572862

LOX Prescription

510(k) clearances

43,512

Adverse events (583 deaths)

121

Recalls

Facilities

Description

OPN NC Ø1.5x15 PTCA catheters

Recalls

Date	Firm	Reason
2022-06-24	Medtronic Inc	Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.