ARROW IPN036097 (REF CV-12123-F)Recalls & reported problems
Teleflex Incorporated · Arrow-Howes(TM) Large-Bore Multi-Lumen Central Venous Catheterization Set 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902122831), received between Aug 26, 2024 and Aug 18, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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.
Reports received per month
Most reported problems
Device problems
- Component Missing1
- Difficult to Advance1
- Disconnection1
- Material Deformation1
- Material Puncture/Hole1
- Physical Resistance/Sticking1
- Separation Problem1
- Unraveled Material1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED "WE FOUND THAT THE THIRD PORT OF THE DEVICE HAD A HOLE, WHICH COMPROMISED ITS FUNCTIONALITY. THE INCIDENT WAS IDENTIFIED IMMEDIATELY DURING THE FIRST DIALYSIS SESSION, WHICH ALLOWED THE SITUATION TO BE CONTROLLED WITHOUT FURTHER COMPLICATIONS." A NEW CATHETER WAS USED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".
Patient problems: Insufficient Information
MAUDE report 22828062 ↗MalfunctionFeb 13, 2025Component Missing; Material Deformation; Component Missing; Material Deformation
IT WAS REPORTED THAT: "THE GUIDE WIRE DOES NOT PROGRESS DESPITE THE WELL-POSITIONED NEEDLE WITH BLOOD FLOWING SPONTANEOUSLY IN 2 DIFFERENT PLACES AND IT HAS SIGNIFICANT DEFORMATION".
Patient problems: Insufficient Information
MAUDE report 21373606 ↗MalfunctionOct 7, 2024Disconnection; Separation Problem; Disconnection; Separation Problem
IT WAS REPORTED "THE TIP OF THE DISTAL ACCESS CAME OUT." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 20384675 ↗MalfunctionAug 26, 2024Unraveled Material; Difficult to Advance; Physical Resistance/Sticking; Unraveled Material; Difficult to Advance; Physical Resistance/Sticking
IT WAS REPORTED THAT: " DURING USE OF THE CATHETER IN THE OPERATING ROOM, BLOCKAGE OF THE METAL GUIDE IN THE NEEDLE WAS OBSERVED. AFTER AN ATTEMPTED GUIDE PROGRESSION, THE DEVICE WAS REMOVED COMPLETELY. THE GUIDE APPEARED ELONGATED IN THE DISTAL PART PROTRUDING FROM THE TIP OF THE NEEDLE. THE PATIENT WAS NOT INJURED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20063199 ↗
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-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
- 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
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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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