ARROW IPN037337Recalls & reported problems
Teleflex Incorporated · Spring-Wire Guide · 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 10801902128901), received between May 7, 2021 and Aug 31, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K914531); 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.
Most reported problems
Device problems
- Deformation Due to Compressive Stress3
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THE SPRING WIRE GUIDE BENT DURING INSERTION. THE ISSUE OCCURED WITH 3 DEVICES ON THE SAME PATIENT AND A FOURTH ATTEMPT WAS SUCCESSFUL. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. THE ADDITIONAL DEVICES ARE CAPTURED IN MDR # 9680794-2022-00531 AND 9680794-2022-00532.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15331943 ↗MalfunctionAug 31, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THE SPRING WIRE GUIDE BENT DURING INSERTION. THE ISSUE OCCURED WITH 3 DEVICES ON THE SAME PATIENT AND A FOURTH ATTEMPT WAS SUCCESSFUL. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. THE ADDITIONAL DEVICES ARE CAPTURED IN MDR # 9680794-2022-00531 AND 9680794-2022-00526.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15331906 ↗MalfunctionAug 31, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THE SPRING WIRE GUIDE BENT DURING INSERTION. THE ISSUE OCCURED WITH 3 DEVICES ON THE SAME PATIENT AND A FOURTH ATTEMPT WAS SUCCESSFUL. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. THE ADDITIONAL DEVICES ARE CAPTURED IN MDR # 9680794-2022-00526 AND 9680794-2022-00532.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15331872 ↗MalfunctionMay 7, 2021Material Separation; Material Separation
CUSTOMER REPORTED "INNER WIRE FAULTY. DURING REMOVAL OF THE GUIDEWIRE FROM THE WIRE HOLDER, THE INNER WIRE CAME OUT". IT WAS REPORTED THE ISSUE WAS DETECTED WHEN PULLING THE GUIDEWIRE OUT OF THE PACKAGE. THE DEVICE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11794454 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K914531. One submission often covers many models, so check the product and lot details in each record.
- Z-3299-2024 · Jul 26, 2024 · Open, ClassifiedArrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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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