ARROW IPN030126Recalls & 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
- 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 00801902111401), received between May 6, 2022 and Jul 8, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Material Rupture1
- Material Twisted/Bent1
- Obstruction of Flow1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " THE GUIDEWIRE BENT DURING INSERTION AND IT WAS NOT POSSIBLE TO PROCEED." THE DEVICE WAS REMOVED AND A NEW KIT WAS USED IN THE SAME INSERTION SITE. THERE WAS NO MEDICAL INTERVENTION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436027 ↗MalfunctionFeb 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT "DURING USE, THE CVC TIP IMMEDIATELY RUPTURED AFTER GUIDE WIRE INSERTION.". ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21431655 ↗MalfunctionFeb 4, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT "NEEDLE IN THE PACKAGE WAS UNABLE TO ASPIRATE". A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305169 ↗MalfunctionMay 6, 2022Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking
IT WAS REPORTED THE DILATOR DIDN'T SLIDE OVER THE GUIDEWIRE. THE USER TRIED TO ENLARGE THE HOLE WITH A DILATOR FROM ANOTHER KIT AND THEN REINSERTED THE DILATOR FROM THE 4-LUMEN KIT AGAIN. IT KEPT NOT ADVANCING IN TO THE SKIN AND BENT AT THE TIP. NO PATIENT HARM WAS REPORTED. THE ISSUE WAS RESOLVED BY USING ANOTHER DILATOR AND FINALLY THE CATHETER PASSED OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14306775 ↗
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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