PRONTO IPN913538Recalls & reported problems
Teleflex Incorporated · Pronto V3, 6F · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156100308), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: PROCEDURE WENT AS PLANNED, BUT WHEN REMOVING THE PRONTO V4 IT STARTED UNRAVELING, AND ENDED UP SEPARATING. ENTIRE CATHETER STAYED ON WIRE SO WE'RE ABLE TO REMOVE EVERYTHING, AND NOTHING THE BROKE OFF IN PATIENT. NO HARM TO PATIENT, OR MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10687640 ↗
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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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