510(k) · Decided
Recalled · Class I · 2026Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep (R) Retrograde Chronic...
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Jun 30, 2011 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 4 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 4 times, including 3 Class I recalls.
- Decided
- Jun 30, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 4 (3 Class I)
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 3 of the 4 devices in this family, counting this one, have a Class I recall.
- This deviceK111117 Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic…Teleflexmedical, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK111900 Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK130192 Nextstep RetrogradeArrow International, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK141051 Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · cites it directly2descendants
- K130192Nextstep RetrogradeArrow International, Inc. · 2013 · cites it directly1descendant
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…Arrow International, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111117 | Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis… | Teleflexmedical, Inc. | 2011 | — |
| +1 | K111900 | Nextstep Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | Class I |
| +1 | K130192 | Nextstep Retrograde | Arrow International, Inc. | 2013 | — |
| +2 | K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic… | Arrow International, Inc. | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), 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 K241581 Hemodialysis Catheterscore 12.3 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2026 | Class I | Z-2159-2026 | Nonconforming Material/Component | 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 may result in withdrawal resistance, prolonged procedure… |
| Apr 10, 2026 | Class I | Z-2156-2026 | Nonconforming Material/Component | 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 may result in withdrawal resistance, prolonged procedure… |
| Apr 10, 2026 | Class I | Z-2158-2026 | Nonconforming Material/Component | 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 may result in withdrawal resistance, prolonged procedure… |
| Feb 4, 2013 | Class II | Z-1007-2015 | Component design/selection | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. |
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 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K111900 (Teleflexmedical, Inc., 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MSD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 2025
MAUDE reports naming product code MSD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 92 | 0 | 118 |
| 2008 | 3 | 89 | 47 | 174 |
| 2009 | 6 | 81 | 49 | 173 |
| 2010 | 4 | 116 | 11 | 306 |
| 2011 | 7 | 70 | 24 | 268 |
| 2012 | 2 | — | 0 | 367 |
| 2013 | 5 | 105 | 1 | 363 |
| 2014 | 8 | 246 | 0 | 506 |
| 2015 | 1 | — | 0 | 550 |
| 2016 | 2 | — | 0 | 532 |
| 2017 | 2 | — | 0 | 484 |
| 2018 | 2 | — | 0 | 463 |
| 2019 | 1 | — | 0 | 645 |
| 2020 | 4 | 106 | 0 | 401 |
| 2021 | 4 | 153 | 0 | 523 |
| 2022 | 0 | — | 0 | 610 |
| 2023 | 0 | — | 0 | 542 |
| 2024 | 0 | — | 0 | 841 |
| 2025 | 1 | — | 0 | 1,054 |
| 2026 | 0 | — | 4 (4) | — |
https://510kreport.com/device/K111117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111117: Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter, Nextstep (R) Retrograde Chronic....” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111117
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026