ARROW IPN000131Recalls & reported problems
Teleflex Incorporated · Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00801902001788), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K924607); 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.
Reports received per month
Most reported problems
Device problems
- Premature Separation1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT: THE ARROW BROKE WHEN HE TRIED TO PUT A CXI IN. THE CXI ALSO BROKE RESULTING IN THEM HAVING NO ACCESS TO THE PATIENT AND HAVING AN ARTERIAL BLEED. ADDITIONAL INFORMATION: THE CXI GOT STUCK INSIDE THE SUPER ARROW FLEX SHEATH, THE SURGEON PULLED HARD WHICH CAUSED THE CXI CONNECTOR HUB TO DISCONNECT FROM THE CATHETER. AFTER THE BLEED PRESSURE WAS HELD FOR 20 MINUTES AND PROTAMINE WAS GIVEN. THE CASE HAD TO BE ABORTED. ALL COMPONENTS WERE REMOVED FROM THE PATIENT AND THE PATIENT WAS REPORTED AS STABLE. NO OTHER HARM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18864790 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K924607. One submission often covers many models, so check the product and lot details in each record.
- Z-1064-2016 · Jan 12, 2016 · TerminatedSuper Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis
- Z-1491-2009 · Feb 11, 2009 · TerminatedArrow Super Arrow-Flex Percutaneous Sheath Introducers
- Z-0088-04 · Oct 22, 2003 · Terminated10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
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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