# K123196: Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath - Pathway: 510(k) (Traditional) - Applicant: Covidien - Decided: Jan 31, 2013 after 112 days - Product code: MSD (Catheter, Hemodialysis, Implanted) - Device class: 2 - Regulation: 21 CFR 876.5540 - Recalls of this device: 49 (4 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K974236 (1999). 14 ancestors in all. 4 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) - K111372: Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)..., Covidien (2011) Summary page 1. - K112477: Palindrome H, SI, Hsi Chronic Catheter, Covidien (2011) Summary page 1. - (no number) Palindrome RT Reverse-Tunneled Catheter: named in the summary without a submission number - (no number) Palindrome SI Chronic Catheter: named in the summary without a submission number - (no number) Palindrome HSI Chronic Catheter: named in the summary without a submission number ## Most influential descendants - 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 - Apr 23, 2025 · Class II · Z-1886-2025: Potential breach of sterile barrier packaging. - Apr 23, 2025 · Class II · Z-1885-2025: Potential breach of sterile barrier packaging. - Apr 23, 2025 · Class II · Z-1889-2025: Potential breach of sterile barrier packaging. - Apr 23, 2025 · Class II · Z-1888-2025: Potential breach of sterile barrier packaging. - Apr 23, 2025 · Class II · Z-1887-2025: Potential breach of sterile barrier packaging. - Mar 15, 2024 · Class II · Z-1635-2024: Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating - Mar 15, 2024 · Class II · Z-1634-2024: Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating - Jun 8, 2022 · Class I · Z-1312-2022: 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-1315-2022: 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-1314-2022: 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-1313-2022: 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 - May 28, 2021 · Class II · Z-2371-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). - May 28, 2021 · Class II · Z-2375-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). - May 28, 2021 · Class II · Z-2372-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). - May 28, 2021 · Class II · Z-2374-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). - May 28, 2021 · Class II · Z-2373-2021: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). - Oct 14, 2015 · Class II · Z-0329-2016: Incorrectly packaged with a 90 degree bend at the distal tip - Oct 14, 2015 · Class II · Z-0331-2016: Incorrectly packaged with a 90 degree bend at the distal tip - Oct 14, 2015 · Class II · Z-0332-2016: Incorrectly packaged with a 90 degree bend at the distal tip - Oct 14, 2015 · Class II · Z-0330-2016: Incorrectly packaged with a 90 degree bend at the distal tip - Oct 14, 2015 · Class II · Z-0333-2016: Incorrectly packaged with a 90 degree bend at the distal tip - Apr 23, 2015 · Class II · Z-1879-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1897-2015: 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-1872-2015: 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-1910-2015: 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-1909-2015: 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-1902-2015: 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-1884-2015: 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-1899-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1870-2015: 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-1877-2015: 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-1885-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1911-2015: 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-1878-2015: 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-1887-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1871-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1869-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1908-2015: Catheters may not meet antimicrobial specification - Apr 23, 2015 · Class II · Z-1868-2015: Catheters may not meet antimicrobial specification ## Indications for use The Palindrome Precision Symmetric Tip Dual Lumen Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral placement. The Palindrome Precision RT Reverse-Tunneled Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion. The Palindrome Precision 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 Palindrome Precision 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 Palindrome Precision 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/K123196 Methodology: https://510kreport.com/methodology