ARROW IPN032903Recalls & reported problems
Teleflex Incorporated · Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902001303), received between Jun 4, 2024 and Jul 30, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (3 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
- Material Twisted/Bent3
- Difficult to Advance2
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2024Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking
IT WAS REPORTED " DIFFICULTIES WITH INSERTING BIOPTOME THROUGH CORDIS DUE TO STICKING AND NOT SMOOTH. SQUEAKING NOISE NOTED DURING BIOPTOME INSERTION. DOCTOR FELT RESISTANCE WITH FEEDING THE BIOPTOME THROUGH THE INTRODUCER AS WELL AS RESISTANCE WITH FEEING THE WIRE INTO THE SHEATH." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19861698 ↗MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "OVER THE LAST MONTH OUR PHYSICIANS HAVE NOTED ISSUES WITH THE PSI BENDING DURING INSERTION AND DIFFICULTIES ADVANCING THE BIOPTOME THROUGH THE CATHETER WITHOUT MEETING RESISTANCE. DURING THIS INCIDENT, STAFF REQUIRED MULTIPLE KITS FOR ONE PROCEDURE DUE TO THE FAILURE OF THE PSI TO FUNCTION. NO PATIENT HARM." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19462118 ↗MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "OVER THE LAST MONTH OUR PHYSICIANS HAVE NOTED ISSUES WITH THE PSI BENDING DURING INSERTION AND DIFFICULTIES ADVANCING THE BIOPTOME THROUGH THE CATHETER WITHOUT MEETING RESISTANCE. DURING THIS INCIDENT, STAFF REQUIRED MULTIPLE KITS FOR ONE PROCEDURE DUE TO THE FAILURE OF THE PSI TO FUNCTION. NO PATIENT HARM." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19462000 ↗MalfunctionJun 4, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent
IT WAS REPORTED "WE WORK IN THE CARDIAC TRANSPLANT CLINIC AND CURRENTLY USE THE PERCUTANEOUS SHEATH INTRODUCER KITS FOR CARDIAC BIOPSIES. OVER THE LAST MONTH OUR PHYSICIANS HAVE NOTED ISSUES WITH THE PSI BENDING DURING INSERTION AND DIFFICULTIES ADVANCING THE BIOPTOME THROUGH THE CATHETER WITHOUT MEETING RESISTANCE." NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19460049 ↗
Other Introducer, catheter devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 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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