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ARROW

TELEFLEX INCORPORATED · Model CS-15312-VF · UDI-DI 10801902154658

MSD Prescription

510(k) clearances

11,428

Adverse events (301 deaths)

270

Recalls

Facilities

Recalls

Date	Firm	Reason
2026-04-10	ARROW INTERNATIONAL, LLC	16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10	ARROW INTERNATIONAL, LLC	16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10	ARROW INTERNATIONAL, LLC	16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10	ARROW INTERNATIONAL, LLC	16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-02-13	Merit Medical Systems, Inc.	16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13	Merit Medical Systems, Inc.	16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13	Merit Medical Systems, Inc.	16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13	Merit Medical Systems, Inc.	16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2025-04-23	Mozarc Medical US LLC	Potential breach of sterile barrier packaging.
2025-04-23	Mozarc Medical US LLC	Potential breach of sterile barrier packaging.

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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.