ARROW IPN920735Recalls & reported problems
Teleflex Incorporated · Arterial Catheterization Set · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902197327), received between Jul 29, 2026 and Sep 3, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (6 reports).
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
- Device Damaged Prior to Use6
- Material Twisted/Bent6
- Failure to Obtain Sample1
- Insufficient Device Problem Information1
- Obstruction of Flow1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Hematoma1
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Device Damaged Prior to Use; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50577260 ↗InjuryAug 31, 2026Insufficient Device Problem Information; Physical Resistance/Sticking
Patient problems: Hematoma; Insufficient Information
MAUDE report 50534276 ↗MalfunctionJul 30, 2026Obstruction of Flow; Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50083155 ↗MalfunctionJul 29, 2026Device Damaged Prior to Use; Material Twisted/Bent
It was reported that five arterial kits from lot number 71F26C0995 were opened for use during the same procedure. Upon opening, the spring wire guide (SWG) contained within each kit was observed to be bent/kinked. The issue was identified prior to patient use, and none of the affected devices were used. There was no patient involvement associated with this event. No patient injury, adverse health consequences, or clinically significant harm were reported. Associated MDRs include 3006425876-2026-00820 (Device #1), 3006425876-2026-00839 (Device #2), 3006425876-2026-00840 (Device #3), 3006425876-2026-00841 (Device #4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50077255 ↗MalfunctionJul 29, 2026Device Damaged Prior to Use; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50077244 ↗MalfunctionJul 29, 2026Device Damaged Prior to Use; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50077220 ↗MalfunctionJul 29, 2026Device Damaged Prior to Use; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50077207 ↗MalfunctionJul 29, 2026Device Damaged Prior to Use; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50077098 ↗
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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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