Permcath 8817680001Recalls & reported problems
Mozarc Medical US LLC · Chronic Silicone Oval Catheter Tray,Staggered Tip,36 cm · Class 2 · Implant
All models of Permcath (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521009841), received between Jan 26, 2024 and Jan 26, 2024 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Chest Pain1
- Myocardial Infarction1
- Nausea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT PRESENTED DUE TO INTERMITTENT CHEST PAIN WITH NAUSEA AFTER GETTING ¿PERMCATH¿ REPLACED AFTER MISSING DIALYSIS. IT WAS ALSO STATED THAT THE PATIENT SUFFERED FROM TYPE 1 SPONTANEOUS MYOCARDIAL INFARCTION WITH UNKNOWN LOCATION LATER AFTER THE PATIENT RECEIVED ¿PERMCATH¿. THE PATIENT WAS HOSPITALIZED FROM ¿(B)(6) 2023¿. IT WAS KNOWN THAT THERE WAS ELEVATED TROPONINS FROM ¿(B)(6) 2023¿= 322NG/L (NANOGRAMS PER LITER) TO 579NG/L ON ¿(B)(6) 2023¿. IT WAS STATED THAT IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY WAS HELD FOR PERMCATH PROCEDURE. IT WAS ALSO UNKNOWN IF HOLDING ANTIPLATELET LED TO CHEST PAIN. THE PATIENT WAS A FORMER SMOKER. DUE TO UNDERLYING METASTATIC LUNG CANCER WITH PROGRESSIVE FUNCTIONAL, GENERAL HEALTH DECLINE AND THERE WAS POOR TOLERANCE OF TREATMENTS. A HEART CATH WAS NOT PURSUED, INSTEAD MEDICAL TREATMENT WITH ASPIRIN AND PALLIATIVE CARE WAS CONSULTED AND TAKEN IN RESPONSE TO THIS AE (ADVERSE EVENT). THE AE WAS ALSO NOT TREATED WITH A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION. THERE WAS NO SURGICAL PROCEDURE DONE. AE (ADVERSE EVENT) WAS SUBMITTED NOW DUE TO THERAPY RELEVANCE. IT WAS MENTIONED THAT BASED ON THE SPONSORS ASSESS
Patient problems: Chest Pain; Myocardial Infarction; Nausea
MAUDE report 18589751 ↗
Other CATHETER, SUBCLAVIAN devices
- Permcath 8817748001Mozarc Medical US LLC · CATHETER, SUBCLAVIAN2 deaths34 reports
- ARROW IPN030063Teleflex Incorporated · CATHETER, SUBCLAVIAN30 reports
- Hemo-Cath® SL18PMedical Components, Inc. · CATHETER, SUBCLAVIAN1 death25 reports
- Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 19 cm 5534190Bard Access Systems, Inc. · CATHETER, SUBCLAVIAN17 reports
- Schon 10800702Angiodynamics, Inc. · CATHETER, SUBCLAVIAN8 reports
- Permcath 8817749001Mozarc Medical US LLC · CATHETER, SUBCLAVIAN7 reports
- ARROW IPN919725Teleflex Incorporated · Catheter, subclavian7 reports
- ARROW IPN919724Teleflex Incorporated · Catheter, subclavian6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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