ARROW IPN920649Recalls & 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: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902196382), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. 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

Material Separation1

Patient problems

Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 7, 2023Material Separation; Material Separation
IT WAS REPORTED THAT "WHEN THEY WERE PUTTING THE DWELL IN THE END PIECE DETACHED AND GOT STUCK IN PATIENTS' TISSUE AS THEY GAINED ACCESS AND WERE PULLING NEEDLE OUT. UPDATE, ON 3/14, THEY DID NOT SAVE THE LOT NUMBER, BUT THEY HAVE THE PRODUCT IN BIOHAZARD BAG TO SEND BACK, THE USER STATED AS THEY INSERTED THE DWELL, GOT IN VEIN, BLOOD RETURN, GUIDEWIRE CAME OUT FINE, WHEN THEY PULLED BACK ON NEEDLE THEY NOTICED 3/4 OF THE CATHETER CAME OUT WITH THE NEEDLE AND REALIZED A PIECE OF CATHETER BROKE OFF IN PT. (CATHETER SEPARATED AND IT WAS A CLEAN SHEER PER USER). THEY CALLED IR TO DO A SCAN, THEY SAID THE CATHETER PIECE [WOULD] WORK ITS WAY OUT OF VESSEL AND IS JUST IN TISSUE RIGHT UNDER SKIN SO NO SURGICAL INTERVENTION WAS NEEDED THEY WILL WAIT AND SEE IF BODY PUSHES IT OUT LIKE A SPLINTER. THEY SAID HIS CONDITION IS THE SAME BEFORE THE DWELL WAS PUT IN SO NO WORSE NO BETTER, THE PATIENT'S DR'S WERE ALREADY IN DISCUSSIONS ABOUT HIM BEING A COMFORT CODE PRIOR TO DWELL GOING IN AS HIS VITALS WERE NOT GOOD PRIOR TO INSERTION. PER USER THE IR DOCTOR SAID IT WILL NOT AFFECT HIS STATE THEY ARE JUST GOING TO SEE IF IT WILL WORK ITS WAY OUT OF THE TISSUE THEY ARE CONTINUING TO MONITOR. THE CU
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 16700809 ↗

Device details

UDI-DI	`10801902196382`
Brand	ARROW
Model	IPN920649
Catalog no.	EDC-00818
Company	Teleflex Incorporated
Product code	FOZ · Catheter, intravascular, therapeutic, short-term less than 30 days
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 8, 2024

Device type (GMDN): Peripheral intravenous cannula

A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

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All Catheter, intravascular, therapeutic, short-term less than 30 days devices →

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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