510(k) · Decided
Recalled · 2008Cannon II Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Feb 13, 2004 as substantially equivalent to K010399 (Diatek, Inc., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 3 of the 15 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 19 times.
- Decided
- Feb 13, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 19
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010399 (2001). 13 later devices descend from it, 2 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- This deviceK040078 Cannon II PlusArrow International, Inc. · 2004
- Descendant · cites it directly · 11 of its ownK092205 Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009
- Descendant · 2 generations on · 10 of its ownK111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R)…Covidien · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK123196 Palindrome Precision H Chronic Catheter, Palindrome Precision SI…Covidien · 2013 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K092205Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009 · cites it directly11descendants
- K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Covidien · 2011 · 2 generations on10descendants
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 3 generations on5descendants
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien · 2013 · 3 generations on4descendants
- K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| 0 (this device) | K040078 | Cannon II Plus | Arrow International, Inc. | 2004 | — |
| +1 | K092205 | Palindrome P Hemodialysis Catheter | Covidien Lp, Formerly Registered AS Kendall | 2009 | — |
| +2 | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid… | Covidien | 2011 | Class I |
| +3 | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | Class I |
| +3 | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic… | Covidien | 2013 | Class I |
| +4 | K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 2 |
| 2013 | 1 | 1 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
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 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC…Summary page 1…e classification MSD, Class III, 21 CFR Part 876.5540, Catheter, Hemodialysis, name: Implanted Legally marketed Arrow Cannon Catheter TM (K010399). devices to which the device is substantially equivalent: Description of the The Arrow Cannon TM 11 Plus consists of a do… | 2001 |
What descends from it? (13)
See all 132 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 |
|---|---|---|---|---|
| Jun 10, 2008 | Not classified | Z-2267-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2264-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2253-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2257-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2258-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2263-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2262-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2256-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2261-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2255-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2268-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2254-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2269-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2259-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2270-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2266-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2252-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2265-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2260-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
The 5 latest of 19 recalls; the web page lists all.
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.
- K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter…Covidien · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi…Covidien · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
What is it indicated for?
The Arrow CannonTM IIPlus is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Cannon TM II Plus 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 CannonTM II Plus is intended for use in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040078: Cannon II Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040078
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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