Prodigy Twist™ TWIST8F-SRecalls & reported problems
Imperative Care, Inc. · 8F Short Prodigy Twist™, 67 cm · Class 2
- 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 00850032079037), received between Dec 24, 2025 and Dec 24, 2025 — classified as 1 injury.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PROCEDURE UTILIZING THIRD-PARTY DEVICES, AN 8F-S PRODIGY CATHETER, AND AN 8F-S PRODIGY TWIST, A VESSEL DISSECTION WAS IDENTIFIED. THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE DISSECTION. THE TREATED VESSELS INCLUDED THE RIGHT FOREARM GRAFT AND THE CEPHALIC VEIN. THERE WAS NO DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE.
Patient problems: Vascular Dissection
MAUDE report 23889290 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.