HEMO-CATH®SILICONE DSL18PRecalls & reported problems
Medical Components, Inc. · 8F X 18CM HEMO-CATH® SILICONE DOUBLE LUMENSILICONE DO CATHETER SETCATHETER SET (CUFF 15CM FROM TIP)(CUFF 15CM F · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908144895), received between Aug 8, 2022 and Oct 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2024Leak/Splash; Leak/Splash
CATHETER WAS LEAKING AROUND THE SITE AND NOT FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20374871 ↗MalfunctionAug 8, 2022Leak/Splash; Leak/Splash
CATHETER FOUND TO ALLOW BLOOD INFUSED IN ONE LUMEN TO FLOW THROUGH THE OTHER LUMEN. THIS RESULTED IN RECIRCULATION OF DIALYSATE AND INADEQUATE DIALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15186652 ↗
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- 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
- ARROW IPN919725Teleflex Incorporated · Catheter, subclavian7 reports
- Permcath 8817749001Mozarc Medical US LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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