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ARROW IPN033929Recalls & 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 10801902005820), received between Nov 20, 2022 and Nov 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1
  • Physical Resistance/Sticking1

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.

  • MalfunctionNov 20, 2022Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

    MEDWATCH REPORT RECEIVED: "DURING CATHETER INSERTION, THE GUIDEWIRE SPLIT AS IT WAS BEING REMOVED. ALL PARTS OF THE GUIDEWIRE WERE REMOVED. INFORMATION SENT TO CENTRAL SERVICE TO TRACK OCCURRENCES. FROM POST-PROCEDURE NOTE: THE VEIN WAS CANNULATED WITH A FINDER NEEDLE. IMMEDIATELY UPON ENTERING THE VEIN DARK, NON-PULSATILE BLOOD DID RETURN. ULTRASOUND WAS USED TO CONFIRM VENOUS PRESSURES. SUBSEQUENTLY THE WIRE WAS FED THROUGH THE NEEDLE AND THE NEEDLE WAS THEN REMOVED. A SMALL SKIN INCISION WAS MADE AT THE PUNCTURE SITE TO ALLOW THE DILATOR TO BE INSERTED. AFTER DILATION, THE CATHETER WAS THEN PLACED OVER THE GUIDEWIRE. TO THIS POINT EVERYTHING WENT WELL. THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED FROM THE PLACED CATHETER BUT BECAME STUCK WITHIN THE CATHETER. THE ENTIRE CATHETER AND GUIDEWIRE WERE REMOVED. THE PROCEDURE WAS ATTEMPTED AGAIN AS ABOVE, AND THE CATHETER WAS SUCCESSFULLY PLACED, AND THE GUIDEWIRE COMPLETELY REMOVED. THE CATHETER WAS SUTURED IN PLACE AND A STERILE DRESSING WAS APPLIED OVER THE SITE."

    Patient problems: Insufficient Information

    MAUDE report 15831617 ↗

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, Classified
    Description/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 · Terminated
    Arrow Three-Lumen CVC
  • Z-1672-2009 · May 8, 2009 · Terminated
    12 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 · Terminated
    12 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

Other Catheter,intravascular,therapeutic,short-term less than 30 days devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page