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ARROW
TELEFLEX INCORPORATED · Model IPN001387 · UDI-DI 10801902128673
MSD
Prescription
1
510(k) clearances
11,428
Adverse events (301 deaths)
270
Recalls
55
Facilities
Description
Arrow-Clark(TM) VectorFlow(TM) Retrograde Hemodialysis Catheterization Set Long-Term Access. Catheter Length, Tip to Cuff: 42 cm
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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Get your free API keyRead the docsData 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.
