ARROW IPN925059Recalls & reported problems
Teleflex Incorporated · Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port (accepts .035" - .038" wire) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902210415), received between Jun 2, 2025 and Jun 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Patient Device Interaction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2025Defective Device; Patient Device Interaction Problem
DURING THE PROCEDURE A FLEX SHEATH WAS USED TO ACCESS THE LEFT FEMORAL ARTERY, THERE WAS CHALLENGE WITH PLACING THE SHEATH, THE SHEATH WAS REMOVED, AND IT WAS DISCOVERED THAT TISSUE FROM THE PATIENT'S ARTERY WAS LEFT ON TOP OF THE INTRODUCER. THE SHEATH'S INTRODUCER WAS NOT LOCKING INTO PLACE. A SECOND SHEATH OF THIS SAME TYPE HAD THE SAME LACK OF LOCK FOR THE INTRODUCER. THE PATIENT HAD HARM TO THE LEFT ILIAC ARTERY, A STENT WAS PLACED TO REPAIR THE DAMAGE. TWO DEVICES - SAME LOT#.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22122888 ↗
Other Introducer, catheter devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.