ARROW IPN037864Recalls & reported problems
Teleflex Incorporated · ARROW ENDURANCE(TM) Extended Dwell Peripheral Catheter System · Class 2
All models of ARROW (1494)
Data updated Oct 16, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902133004), received between Jan 21, 2022 and Jan 11, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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.
Recalls naming this device
- May 19, 2023Open, Classified
Potential for catheter separation or leakage
Z-1826-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Difficult to Remove1
- Obstruction of Flow1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2023Break; Difficult to Remove
AN ELDERLY FEMALE IN-PATIENT (EMERGENCY-TO-INPATIENT) FOR POSSIBLE CARDIOVASCULAR (CV) DISEASE. DURING INSERTION OF IN-SWELLING IV THE RN NOTED SOME RESISTANCE WHEN SHE TRIED TO ADVANCE THE CATHETER. WHEN SHE PULLED THE CATHETER OUT IT APPEARED TO BE SHORTENED AND BROKEN OFF. RADIOLOGIST NOTIFIED AND X-RAY OF LEFT FOREARM TAKEN. ALLEGEDLY A 17MM PIECE OF CATHETER RETAINED IN SOFT TISSUE. PATIENT HAS SUBSEQUENTLY BEEN DISCHARGED.
Patient problems: Foreign Body In Patient
MAUDE report 16136873 ↗MalfunctionJan 21, 2022Obstruction of Flow; Obstruction of Flow
ENDURANCE CATHETER PLACED IN PATIENT ON (B)(6) 2021. IT WORKED WELL AND MEDICATIONS WERE GIVEN FOR 24 HOURS. ON (B)(6) 2021, THEY COULD NOT FLUSH THE LINE. THE LINE WAS REMOVED FROM THE PATIENT. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315198 ↗
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-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 · each recall links to the FDA recall notice
- 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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