VenaCure 1470 Pro PDMS00252Recalls & reported problems
Quanta System SPA · Distributed by: Angiodynamics Inc. 603 Queensbury Ave., NY 12804 USA · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This VenaCure 1470 Pro surgical laser is used for vein procedures. Most of the 42 reports that name its identifier describe the laser failing to produce output or power up, so treatment could not proceed, with no patient effects noted; 1 injury report mentions blood clots found at follow-up after treatment. There were no deaths. No recalls name this device.
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
- 42
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08033945938925), received between Oct 30, 2019 and Jun 11, 2024 — classified as 1 injury, 41 malfunctions.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (13 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
- Therapeutic or Diagnostic Output Failure13
- Output Problem12
- Connection Problem3
- Failure to Power Up3
- Use of Device Problem3
- Appropriate Device Problem Term/Code Not Available2
- Defective Device2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Known Impact Or Consequence To Patient4
- Thrombosis/Thrombus1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A VENACURE 1470 PRO LASER. THE END USER REPORTED THAT THEY RECENTLY HAD SEVERAL PATIENT HAVE EHITS {ENDOTHERMAL HEAT-INDUCED THROMBOSIS} DURING THEIR 1 WEEK FOLLOW UPS POST EVLT.
Patient problems: Thrombosis/Thrombus
MAUDE report 19508093 ↗MalfunctionAug 22, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATO WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15266221 ↗MalfunctionAug 19, 2022No Display/Image
DEVICE DISPALY NOT WORKING DURING TREATMENT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15256872 ↗MalfunctionAug 19, 2022Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15256871 ↗MalfunctionAug 9, 2022Connection Problem; Connection Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189935 ↗MalfunctionJul 15, 2022Therapeutic or Diagnostic Output Failure
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15025448 ↗MalfunctionJul 15, 2022Therapeutic or Diagnostic Output Failure
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15025431 ↗MalfunctionJun 16, 2022Failure to Power Up; Failure to Power Up
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711271 ↗MalfunctionJun 14, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14684253 ↗MalfunctionJun 14, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14684249 ↗MalfunctionMay 23, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14468714 ↗MalfunctionMay 12, 2022Defective Device
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14367715 ↗MalfunctionApr 7, 2022Defective Device
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14039691 ↗MalfunctionFeb 17, 2022Break; Break
THE LASER HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13547488 ↗MalfunctionDec 21, 2021Mechanical Problem; Mechanical Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13050770 ↗MalfunctionDec 16, 2021Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13019125 ↗MalfunctionNov 16, 2021Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12818363 ↗MalfunctionNov 11, 2021Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12795617 ↗MalfunctionNov 11, 2021Therapeutic or Diagnostic Output Failure
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12792225 ↗MalfunctionOct 28, 2021Defective Component
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12710455 ↗MalfunctionOct 1, 2021Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12559937 ↗MalfunctionSep 16, 2021Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12480937 ↗MalfunctionJul 31, 2021Connection Problem; Connection Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12257185 ↗MalfunctionJun 25, 2021Failure to Power Up; Failure to Power Up
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12068519 ↗MalfunctionJun 23, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12050834 ↗
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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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