ARROW IPN921175Recalls & reported problems
Teleflex Incorporated · Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902201109), received between Mar 31, 2026 and Aug 7, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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
- Fluid/Blood Leak2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174087 ↗MalfunctionAug 7, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174085 ↗MalfunctionMay 20, 2026Material Deformation
IT WAS REPORTED THAT "DURING THE PROCEDURE, THE OPERATING PHYSICIAN FOUND THE SHEATH TIP DEFECTIVE (DISTAL LUMEN IRREGULAR). THE PHYSICIAN OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229100 ↗InjuryMar 31, 2026
THE PATIENT WAS PLACED ON ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION] AFTER A VFIB [VENTRICULAR FIBRILLATION] ARREST AND VFIB STORM. AROUND 35 HOURS LATER, THE TEAM NOTED BLOOD COMING OUT OF THE ECMO REPERFUSION CANULA THAT WAS NOTED TO BE CRACKED AROUND THE PERMANENT STOPCOCK ON THE DEVICE. THE CANULA NEEDED TO BE REMOVED AND REPLACED UNDER STERILE CONDITIONS AND THE PATIENT REQUIRED 3 UNITS OF BLOOD AS A RESULT OF BLOOD LOSS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24741543 ↗
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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