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OTW TAKERU

KANEKA CORPORATION · Model DC-PY1530UA1 · UDI-DI 04540778169692

LOX Prescription

510(k) clearances

43,512

Adverse events (583 deaths)

121

Recalls

Facilities

Description

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).

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.