510(k) Report

510(k) · Cleared

Recalled · Class I · 2026

Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde Replacement HU

K141051510(k) SpecialCleared Jul 7, 201474-day reviewClass II21 CFR 876.5540Recalls 1 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arrow International, Inc. · MSD Catheter, Hemodialysis, Implanted

Cleared on Jul 7, 2014 as substantially equivalent to K111900 (Teleflexmedical, Inc., 2011) and 2 other predicates after a 74-day review. Its family tree reaches back 5 generations to 2001. 3 of the 8 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.

Decided
Jul 7, 2014
Review
74 days
Class
Class II
Product code
MSD
Recalls
1 (1 Class I)
Predicates
3

Its longest line of descent runs back 5 generations to K010399 (2001). 7 ancestors in all. No later device cites it as a predicate yet. 3 of the 8 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2002: 1 other ancestor2011: 1 other ancestor, 1 with a Class I recall1K010399 · Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC (32 CM), CC3200PC (36 CM) · Diatek, Inc. · 2001 · recalledK040260 · Integral Hemodialysis Catheter · Arrow Int'L. · 2004 · recalledK102238 · Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter · Teleflexmedical, Inc. · 2011 · recalledK111900 · Nextstep Antegrade Chronic Hemodialysis Catheter · Teleflexmedical, Inc. · 2011 · Class I recallK130192 · Nextstep Retrograde · Arrow International, Inc. · 20132000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor, 1 with a Class I recall1 K130192 · Nextstep Retrograde · Arrow International, Inc. · 2013K111900 · Nextstep Antegrade Chronic Hemodialysis Catheter · Teleflexmedical, Inc. · 2011 · Class I recallK102238 · Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter · Teleflexmedical, Inc. · 2011 · recalledK040260 · Integral Hemodialysis Catheter · Arrow Int'L. · 2004 · recalledK010399 · Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC (32 CM), CC3200PC (36 CM) · Diatek, Inc. · 2001 · recalled−50
  1. Root · 5 generations backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
  2. 4 generations backK040260 Integral Hemodialysis CatheterArrow Int'L. · 2004 · Recalled
  3. 3 generations backK102238 Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled
  4. 2 generations backK111900 Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled (Class I)
  5. 1 generation backK130192 Nextstep RetrogradeArrow International, Inc. · 2013
  6. This deviceK141051 Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014

Class I recalls in this family

  • K111900 Nextstep Antegrade Chronic Hemodialysis Catheterdirect predicate · 2011
  • K111117 Cannon II Plus Chronic Hemodialysis Catheter…2 generations back · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K010399Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC…Diatek, Inc.20012
−4K040260Integral Hemodialysis CatheterArrow Int'L.200415
−3K102238Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc.20111
−2K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc.2011Class I
−1K130192Nextstep RetrogradeArrow International, Inc.2013—
0 (this device)K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic…Arrow International, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
201111
FIG. 1 — Lineage of K141051, 2001–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MSD device

  1. #1 K241581 Hemodialysis Catheterscore 12.3 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K111900Nextstep Antegrade Chronic Hemodialysis Catheter
Summary page 1
…Kit, Repair, Catheter, Hemodialysis (Hub Set only) 3. Predicate Devices Predicate 1: Arrow NextStep Antegrade Chronic Hemodialysis Catheter (K111900) Predicate 2: Arrow NextStep Retrograde Chronic Hemodialysis Catheter (K130192) Predicate 3: Arrow NextStep Retrograde Repl…
Teleflexmedical, Inc.2011Class I
*K130192Nextstep Retrograde
Summary page 1
…edicate Devices Predicate 1: Arrow NextStep Antegrade Chronic Hemodialysis Catheter (K111900) Predicate 2: Arrow NextStep Retrograde Chronic Hemodialysis Catheter (K130192) Predicate 3: Arrow NextStep Retrograde Replacement Hub Set (K020430) 4. Device Description The Arrow VectorFlow Antegrade…
Arrow International, Inc.2013—
*K020430Diatek Connector Assembly Replacement Kit (Cark)
Summary page 1
…lysis Catheter (K111900) Predicate 2: Arrow NextStep Retrograde Chronic Hemodialysis Catheter (K130192) Predicate 3: Arrow NextStep Retrograde Replacement Hub Set (K020430) 4. Device Description The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter (herein referred to as the proposed VF…
Diatek, Inc.20022

Also cleared against K111900: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 10, 2026Class IZ-2157-2026Nonconforming Material/Component16F 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 may result in withdrawal resistance, prolonged procedure…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
  • K111117Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep (R) Retrograde…Teleflexmedical, Inc. · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 13 Class I recalls

What does this lineage say?

  • The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • 6 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
  • 1 other device also cites its predicate K111900.

How does its category compare?

All MSD devices

MSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MSD

1in 2025

2007: 72008: 32009: 62010: 42011: 72012: 22013: 52014: 82015: 12016: 22017: 22018: 22019: 12020: 42021: 42025: 1
2007high 8 (2014) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSD

153in 2021

2007: 92 days median2008: 89 days median2009: 81 days median2010: 116 days median2011: 70 days median2013: 105 days median2014: 246 days median2020: 106 days median2021: 153 days median
2007high 246 (2014) · low 70 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MSD

1in 2013

2008: 472009: 492010: 112011: 242013: 12026 (partial year): 4, 4 Class I
2007high 49 (2009) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MSD

1,054in 2025

2007: 1182008: 1742009: 1732010: 3062011: 2682012: 3672013: 3632014: 5062015: 5502016: 5322017: 4842018: 4632019: 6452020: 4012021: 5232022: 6102023: 5422024: 8412025: 1,054
2007high 1,054 (2025) · low 118 (2007)2025

MAUDE reports naming product code MSD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077920118
200838947174
200968149173
2010411611306
201177024268
20122—0367
201351051363
201482460506
20151—0550
20162—0532
20172—0484
20182—0463
20191—0645
202041060401
202141530523
20220—0610
20230—0542
20240—0841
20251—01,054
20260—4 (4)—

What is it indicated for?

The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are…

Read the full statement (186 words)

The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Retrograde Chronic Hemodialysis Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow VectorFlow catheter is intended for use in adult patients.

The Arrow VectorFlow Retrograde Replacement Hub Set is indicated for use in the replacement of a Arrow VectorFlow Retrograde hub connection assembly that has been damaged.

The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow VectorFlow Antegrade Chronic Hemodialysis Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow VectorFlow catheter is intended for use in adult patients.

Indications for use as stated in the FDA summary.

Also cleared against K111900

1 other device cites the same predicate.

  • K130192Nextstep RetrogradeArrow International, Inc. · 2013

More from Arrow International, Inc.

19 FDA decisions under this applicant name. See the company

  • K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 202011 Class I recalls
  • K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 20201 Class I recall
  • K190101UltraFlex IABArrow International, Inc. · 20191 Class I recall
  • K190117Fiberoptix IABArrow International, Inc. · 2019
  • K162820AC3 Series IABP SystemArrow International, Inc. · 20172 Class I recalls

Recent decisions in MSD

The MSD category page

  • K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025
  • K210461End CapMedical Components Inc (Medcomp) · 2021
  • K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2021
  • K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc. · 2021
  • K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc. · 2021

https://510kreport.com/device/K141051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141051: Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde Replacement HU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141051

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026