ARROW IPN037845Recalls & reported problems
Teleflex Incorporated · ARROW ENDURANCE Extended Dwell Peripheral Catheter System · Class 2
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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902132915), received between Jun 19, 2023 and Jun 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K163513); 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 Separation1
Patient problems
- Foreign Body In Patient1
- Infiltration into Tissue1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2023Material Separation; Material Separation
IT WAS REPORTED THE CUSTOMER STATES THAT 22G 6CM WAS PUT IN "SMALL VEIN NEAR RADIAL ARTERY" ON APPROXIMATLEY (B)(6) OR (B)(6). THE USER BELIEVES POTASSIUM WAS PUT THROUGH THE CATHTER. THE PATIENT COMPLAINED AND THEY NOTED THE CATHETER INFILTRATED. UPON REMOVAL OF CATHETER THEY THOUGHT A PIECE OF THE CATHETER BROKE OFF AND AN X-RAY WAS TAKEN. A VASCULAR SURGEON WAS CALLED AND SUCCESSFULLY REMOVED THE PIECE OF CATHETER. THE PATIENT WAS REPORTED TO BE "FINE" AND DISCHARGED PER CUSTOMER. MEDWATCH REPORT RECEIVED STATES: "ON (B)(6) 2023 A SIX CM LONG PERIPHERAL IV (PIV) WAS INSERTED AT 20:30, AND ON (B)(6) 2023 AT 21:55 THE PIV WAS REMOVED DUE TO REPORTED PAIN AT SITE. WHEN PIV REMOVED, ONLY 1 CM REMAINING. PHYSICIANS WERE NOTIFIED AND EXAM / DIAGNOSTICS PERFORMED. SURGERY PERFORMED ON (B)(6) 2023 FOR REMOVAL OF THE RETAINED IV CATHETER."
Patient problems: Foreign Body In Patient; Infiltration into Tissue; Pain
MAUDE report 17151557 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K163513. One submission often covers many models, so check the product and lot details in each record.
- Z-1826-2023 · May 19, 2023 · Open, ClassifiedARROW Endurance Extended Dwell Peripheral Catheter System
- Z-0837-2020 · Dec 6, 2019 · TerminatedArrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
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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