ARROW IPN919725Recalls & reported problems
Teleflex Incorporated · Two-Lumen Hemodialysis Catheter for High Volume Infusions · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902190373), received between Jul 13, 2026 and Sep 18, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K895417); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent3
- Break1
- Complete Blockage1
- Deformation Due to Compressive Stress1
- Device-Device Incompatibility1
- Failure to Disconnect1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829729 ↗MalfunctionSep 10, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715935 ↗MalfunctionSep 10, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715635 ↗MalfunctionSep 3, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50577285 ↗MalfunctionAug 21, 2026Failure to Disconnect; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50383723 ↗MalfunctionJul 20, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884433 ↗MalfunctionJul 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25797330 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K895417. One submission often covers many models, so check the product and lot details in each record.
- Z-2381-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
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 IPN919724Teleflex Incorporated · Catheter, subclavian6 reports
- Soft-Cell PC Dialysis Catheter Kit 12.5 F x 19 cm 5533190Bard Access Systems, Inc. · CATHETER, SUBCLAVIAN5 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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