Catheter, Hemodialysis, Implanted, Coated
Gastroenterology, Urology · 21 CFR 876.5540
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Recent MDR events
98 adverse event reports on file
- PALINDROMEMay 29, 2025MalfunctionCovidien Llc1282497-2025-00369
- PALINDROMEMay 28, 2025MalfunctionCovidien Llc1282497-2025-00356
- PALINDROMEApr 22, 2025MalfunctionMozarc Medical Us Llc21881353
- PALINDROMEApr 10, 2025MalfunctionCovidien Llc1282497-2025-00229
- PALINDROMEMar 21, 2025InjuryCovidien Llc1282497-2025-00178
- PALINDROMEAug 6, 2024MalfunctionCovidien Llc1282497-2024-00294
- PALINDROMEAug 6, 2024InjuryCovidien Llc1282497-2024-00295
- PALINDROMEAug 6, 2024InjuryCovidien Llc1282497-2024-00296
- PALINDROMEAug 6, 2024InjuryCovidien Llc1282497-2024-00297
- PALINDROMEAug 6, 2024MalfunctionCovidien Llc1282497-2024-00298
Event type breakdown
Recalls
30 recall events for this product code
- Covidien LLCTerminatedNov 24, 2015
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Incorrectly packaged with a 90 degree bend at the distal tip
Z-0329-2016 · View FDA record ↗ - Covidien LLCTerminatedNov 24, 2015
Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm
Incorrectly packaged with a 90 degree bend at the distal tip
Z-0330-2016 · View FDA record ↗ - Covidien LLCTerminatedNov 24, 2015
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Incorrectly packaged with a 90 degree bend at the distal tip
Z-0331-2016 · View FDA record ↗ - Covidien LLCTerminatedNov 24, 2015
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Incorrectly packaged with a 90 degree bend at the distal tip
Z-0332-2016 · View FDA record ↗ - Covidien LLCTerminatedNov 24, 2015
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Incorrectly packaged with a 90 degree bend at the distal tip
Z-0333-2016 · View FDA record ↗ - Covidien LLCTerminatedJul 1, 2015
Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm
Catheters may not meet antimicrobial specification
Z-1850-2015 · View FDA record ↗ - Covidien LLCTerminatedJul 1, 2015
Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm
Catheters may not meet antimicrobial specification
Z-1851-2015 · View FDA record ↗ - Covidien LLCTerminatedJul 1, 2015
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Catheters may not meet antimicrobial specification
Z-1852-2015 · View FDA record ↗ - Covidien LLCTerminatedJul 1, 2015
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Catheters may not meet antimicrobial specification
Z-1853-2015 · View FDA record ↗ - Covidien LLCTerminatedJul 1, 2015
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Catheters may not meet antimicrobial specification
Z-1854-2015 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Cardinal Health Costa Rica, S.a.
-- Alajuela, CR
Covidien
TIJUANA, B.C. Mexico, MX
Voma Ecza Deposu Medikal Urunler San. Tic. A.s.
IZMIR, TR
Sterigenics U.s., Llc
Queensbury, NY, US
Covidien Llc
MANSFIELD, MA, US
Mozarc Medical Us Llc
Mansfield, MA, US
Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti
Maltepe Istanbul, TR
510(k) clearances
2 clearances for this product code