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CROSSTELLA OTW

KANEKA CORPORATION · Model BD-F30020MW · UDI-DI 04540778160491

LIT Prescription

510(k) clearances

35,722

Adverse events (181 deaths)

Recalls

Facilities

Description

CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm).

Recalls

Date	Firm	Reason
2025-12-03	Boston Scientific Corporation	Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to
2025-07-21	SUMMA THERAPEUTICS, LLC	Potential for the balloon in the device to not meet burst specifications.
2024-12-10	ev3 Inc	There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
2024-09-19	Covidien LP	Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
2021-12-17	Covidien Llc	The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remo
2021-07-19	Cordis Corporation	The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to
2021-07-14	Ostial Corporation	Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complicat
2020-08-26	ev3 Inc.	Labeling discrepancy for the Rated Burst Pressure (RBP) value.
2020-01-08	Cordis Corporation	Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
2019-10-11	Nucryo Vascular Inc.	Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.

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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.