ARROW IPN037859Recalls & reported problems
Teleflex Incorporated · ARROW ENDURANCE(TM) Extended Dwell Peripheral Catheter System · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902132908), received between Nov 15, 2018 and May 20, 2021 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 19, 2023Open, Classified
Potential for catheter separation or leakage
Z-1826-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Break1
- Fluid/Blood Leak1
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2021Material Separation; Material Separation
THE COMPLAINT IS REPORTED AS: DURING REMOVAL, THE CATHETER SEPARATED IN PATIENT'S RIGHT FOREARM AFTER 20 DAYS INSITU AND A PIECE OF THE CATHETER WAS RETAINED IN THE PATIENT'S VEIN. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR RIGHT FOREARM EXPLORATION WITH REMOVAL OF FOREIGN BODY. THE CATHETER WAS REMOVED FROM THE PATIENT AND ULTRASOUND CONFIRMED NO EVIDENCE OF CATHETER OR FOREIGN BODY WAS SEEN. THE PATIENT TOLERATED THE OPERATION WITH NO COMPLICATIONS AND WAS TRANSFERRED TO THE PACU IN STABLE CONDITION. THE OPERATIVE NOTES STATE: "WE CIRCUMFERENTIALLY DISSECTED THE VEIN AND PERFORMED A SMALL VENOTOMY TO REMOVE THE CATHETER. UNFORTUNATELY THE CATHETER WAS ADHERED TO THE VEIN WALL. WE THEN TRANSECTED THE VEIN AND PULLED THE CATHETER OUT IN IT'S ENTIRETY. WE RE-EVALUATED THE FOREARM WITH ULTRASOUND AND THERE WAS NO EVIDENCE OF A CATHETER OR FOREIGN BODY SEEN."
Patient problems: Foreign Body In Patient
MAUDE report 11859731 ↗MalfunctionMay 13, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THERE WAS BLEEDING FROM THE END OF THE CATHETER. THE NURSE FOUND THE END PIECE HAD COME OFF AND HAD TO REMOVE THE LINE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11823549 ↗InjuryMar 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
THE COMPLAINT IS REPORTED AS: INSERTER ACCESSED VESSEL, ENGAGED THE GUIDEWIRE WITHOUT INCIDENT, AND THEN BEGAN TO ADVANCE THE CATHETER OVER THE GUIDEWIRE. INSERTER MET RESISTANCE AND PULLED CATHETER BACK OVER NEEDLE. CATHETER WAS SHEARED. IR (INTERVENTIONAL RADIOLOGY) WAS CONSULTED. CATHETER TIP RETRIEVED BY CUTDOWN. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: Foreign Body In Patient
MAUDE report 11447372 ↗InjuryNov 15, 2018Break
DURING THE PLACEMENT OF AN ARROW ENDURANCE PERIPHERAL CATHETER, IT WAS NOTED THAT THE CATHETER APPEARED TO HAVE BROKEN OFF INSIDE THE PATIENT. THE PHYSICIAN WAS NOTIFIED. X-RAY OF LEFT UPPER ARM DID NOT NOTE ANY FOREIGN BODIES. VEIN APPEARED TO HAVE PHLEBITIS, AND PHYSICIAN BELIEVED HE NOTED FRAGMENT ON ULTRASOUND. PATIENT TAKEN TO THE OPERATING ROOM FOR EXPLORATION AND INTERVASCULAR FOREIGN BODY REMOVAL. NO FOREIGN BODY FOUND. PATIENT CONTINUES TO BE TREATED FOR ADMITTING DIAGNOSIS OF INTERCEREBRAL HEMORRHAGE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8078103 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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