# K112477: Palindrome H, SI, Hsi Chronic Catheter - Pathway: 510(k) (Special) - Applicant: Covidien - Decided: Sep 28, 2011 after 30 days - Product code: NYU (Catheter, Hemodialysis, Implanted, Coated) - Device class: 2 - Regulation: 21 CFR 876.5540 - Recalls of this device: 65 (3 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K974236 (1999). 13 ancestors in all. 5 later devices descend from it; 1 cites it directly. 3 of 19 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating, Tyco Healthcare Group (2006) Summary page 1. - K060972: Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby), Kendall (2006) Summary page 1. - K062671: 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire), Kendall (2006) Summary page 1. - K111372: Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)..., Covidien (2011) Summary page 1. ## Most influential descendants - K123196: Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath (2013), 4 descendants of its own - K140884: Symetrex Long Term Hemodialysis Catheter (2014), 3 descendants of its own - K171618: Symetrex Long Term Hemodialysis Catheter (2017), 2 descendants of its own - K173667: 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes (2018), 1 descendant of its own - K202176: Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (2020), 0 descendants of its own ## Recalls of this device - Jun 8, 2022 · Class I · Z-1319-2022: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use - Jun 8, 2022 · Class I · Z-1317-2022: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use - Jun 8, 2022 · Class I · Z-1318-2022: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use - Apr 23, 2015 · Class II · Z-1911-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1877-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1902-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1893-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1889-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1884-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1873-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1860-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1857-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1909-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1885-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1910-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1886-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1901-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1859-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1892-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1861-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1899-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1903-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1864-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1863-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1858-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z1855-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1865-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1888-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1898-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1875-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1876-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1900-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1854-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1891-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1894-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z1856-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1890-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1880-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1905-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1895-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1878-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1879-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1882-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1896-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1862-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1904-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1853-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1874-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1883-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1897-2015: Catheters may not meet antimicrobial specification ## Indications for use The PalindromeTM H Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. The PalindromeTM SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing. The PalindromeTM HSI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion, It may be inserted either percutaneously or by cutdown. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing. Source page: https://510kreport.com/device/K112477 Methodology: https://510kreport.com/methodology