ARROW IPN030168Recalls & reported problems
Teleflex Incorporated · Arrow-Howes(TM) Quad-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter · 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 10801902102345), received between Dec 21, 2021 and Dec 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
1 other recall cover devices cleared under the same FDA submission (K962577); 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 Fragmentation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2021Material Fragmentation; Material Fragmentation
THE COMPLAINT IS REPORTED AS: CVC INSERTED AND UNEVENTFUL. AFTER INSERTION IT WAS NOTICED THE TIP OF THE DILATOR WAS MISSING. X-RAYS SHOW THAT IT IS STILL IN THE PATIENT. AT THE TIME OF THIS REPORT THE PATIENT HAD BEEN EXTUBATED AND DOING WELL. CVC REMAINED IN PLACE. IT WAS UNKNOWN IF ANY INTERVENTION WAS PLANNED TO REMOVE THE DEVICE. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 13054450 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K962577. One submission often covers many models, so check the product and lot details in each record.
- Z-1497-2009 · Feb 11, 2009 · TerminatedArrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters)
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.
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