VSI IPN913184Recalls & reported problems
Teleflex Incorporated · VSI Guidewires · Class 2
All models of VSI (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156105808), received between Oct 10, 2023 and Oct 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (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. 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
- Difficult to Advance1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance
IT WAS REPORTED THAT: DURING PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT, THERE WAS DIFFICULTY ADVANCING THE ACCUSTICK SYSTEM OVER THE MICROWIRE. THE MICROWIRE WAS PHYSICALLY INSPECTED AND NO CLEAR HIGH GRAD KINKING OR DAMAGE TO THE PORTION OF WIRE THAT THE ACCUSTICK SYSTEM WOULD NOT ADVANCE OVER. DURING RETRYING TO REPLACE THE ACCUSTICK SYSTEM OVER THE WIRE, THE WIRE SNAPPED AND BROKE. THE WIRE WAS SUCKED INTO THE RIGHT RENAL COLLECTION SYSTEM. ATTEMPTS WERE MADE TO RETRIEVE THE RETAINED FRAGMENT WITHOUT SUCCESS. UROLOGY WAS CONSULTED WITH THE PLAN TO REMOVE THE WIRE AFTER THE PATIENT STABILIZED FROM THE SEPTIC EVENT. THE PATIENT WAS TAKEN TO OPERATING ROOM ON (B)(6) 2023 FOR UROLOGY TO REMOVE THE RETAINED WIRE FRAGMENT. PATIENT PRESENTED TO THE EMERGENCY ROOM FROM THEIR NURSING HOME FOR SEIZURE LIKE ACTIVITY. PATIENT WAS TRANSFERRED TO THE CCU AFTER INTUBATION FOR MANAGEMENT OF SEPTIC SHOCK, HYPOXIC RESPIRATORY FAILURE, SEIZURE LIKE ACTIVITY, BILATERAL URETERAL CALCULI WITH BILATERAL HYDRONEPHROSIS, ENCEPHALOPATHY. ADDITIONAL INFORMATION: THE PATIENT'S CONDITION PREOPERATIVELY WAS SEPSIS, BILATERAL HYDRONEPHROSIS AND SEIZURE ACTIVITY. DURING A BILATERAL NEPHROSTOMY TUBE PLACEMENT, AC
Patient problems: Foreign Body In Patient
MAUDE report 17903139 ↗
Other Wire, guide, catheter devices
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- 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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