ARROW IPN036098Recalls & 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
- 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 10801902122824), received between Jan 10, 2025 and Jan 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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
- Material Frayed1
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.
MalfunctionJan 10, 2025Material Frayed; Material Frayed
IT WAS REPORTED THAT: "A 12FR SHILEY-TYPE CENTRAL VENOUS CATHETER (CVC) WAS IMPLANTED IN A PATIENT TO COLLECT CELLS FOR AN AUTOLOGOUS BMT. WHEN THE GUIDE WIRE WAS REMOVED, THE DOCTOR NOTICED A GREAT DEAL OF RESISTANCE WHEN IT CAME OUT. THE GUIDE WIRE WAS EVEN FRAYED. AS THERE WAS NO SUCCESS IN REMOVING THE GUIDE WIRE, IT WAS NECESSARY TO REMOVE THE CVC."
Patient problems: Insufficient Information
MAUDE report 21123366 ↗
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
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page