ARROW IPN036855Recalls & reported problems
Teleflex Incorporated · Arrow-Howes(TM) Large-Bore Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter for High Volume Infusions · Class 2 · Implant
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 60801902122089), received between May 6, 2022 and May 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K970864); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Physical Resistance/Sticking1
- Unraveled Material1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking
COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "THE ADVANCED PRACTICE PROVIDER (APP) WAS PLACING A LINE FOR CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). ULTRASOUND WAS USED TO FIND VESSEL, THE GUIDE WIRE WAS PLACED, NEEDLE REMOVED, SMALL INCISION MADE, AND LINE WAS PLACED. WHILE REMOVING THE GUIDE WIRE IT BECAME WHAT FELT LIKE "STUCK". UPON REMOVAL THE "HOOKED" PART OF THE GUIDE WIRE WAS FRAYED."
Patient problems: Insufficient Information
MAUDE report 14312630 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K970864. One submission often covers many models, so check the product and lot details in each record.
- Z-2376-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
- Z-1290-2022 · May 5, 2022 · TerminatedArrow Three-Lumen CVC
- Z-1672-2009 · May 8, 2009 · Terminated12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. The large-bore multiple-lumen catheter permits veno
- Z-1671-2009 · May 8, 2009 · Terminated12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. The large-bore multiple-lumen catheter permits venous
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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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