ARROW IPN000132Recalls & reported problems
Teleflex Incorporated · 5 FR Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Intergral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band · Class 2
Data updated Oct 13, 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 00801902001795), received between Jan 27, 2025 and Jan 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE USER WAS UNABLE TO INSERT A DEVICE INTO THE SHEATH; THE LUMEN OF THE SHEATH APPEARED TO BE OCCLUDED/BLOCKED. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW KIT TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21240720 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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