Guidewire 5583705Recalls & reported problems
Bard Access Systems, Inc. · VC GUIDEWIRE STR 70CM · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Bard Access VC guidewire is a thin wire used to help thread catheters and other devices into blood vessels. The 43 reports mostly describe the wire being put together backwards inside its packaging hoop, so the stiff end ends up where the soft tip belongs; a few mention the wire being hard to advance or ending up in the wrong position. No deaths or injuries are reported. One open recall, started July 2024, covers guidewires built with the ends reversed.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00801741085451), received between Jan 17, 2020 and May 20, 2024 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (42 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 10, 2024Open, Classified
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.
Z-3062-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Component Misassembled42
- Difficult to Advance4
- Improper or Incorrect Procedure or Method1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354538 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354440 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354390 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354327 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354271 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354249 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354200 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354184 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354159 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354141 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354117 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE 17 LOT SAMPLES, COMPONENT MIS-ASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354088 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353988 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353920 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353917 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING THE EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353878 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING THE EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353819 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE 17 LOT SAMPLES, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353813 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING THE EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353806 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353726 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING THE EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353659 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING THE EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353657 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING THE EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353615 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING THE EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353605 ↗MalfunctionMay 20, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING THE EVALUATION OF THE LOT SAMPLE, COMPONENT MISASSEMBLED WAS ALLEGEDLY IDENTIFIED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353596 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.