ARROW IPN033088Recalls & reported problems
Teleflex Incorporated · 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 00801902099679), received between Nov 22, 2023 and Sep 24, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Material Separation1
- Material Twisted/Bent1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2025Material Separation; Material Separation
IT WAS REPORTED THAT "THE THIRD LUMEN CONNECTION CAME OFF COMPLETELY." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 23132625 ↗MalfunctionMar 12, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED "THE CATHETER HAD BEEN PULLING AIR. THE CANNULA WAS USED TO PUNCTURE THE FEMORAL VEIN AND THE CANNULA DREW AIR DURING ASPIRATION DESPITE BEING CLEARLY IN THE VESSEL. THE AIR WAS DRAWN WHILE THE SYRINGE WAS STILL CONNECTED. THIS WAS DETECTED DURING USE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18883948 ↗MalfunctionDec 27, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE DILATOR TIP WAS BENT SO THAT THE USER COULD NOT INSERT DURING USE. THEREFORE, A NEW KIT (LOT#: UNKNOWN) WAS USED INSTEAD. NO INJURY TO THE PATIENT OCCURRED". THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18401286 ↗MalfunctionNov 22, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT "THE ARS WAS FOUND LEAK DURING USED ON THE PATIENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18194244 ↗
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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