Paladin 5x30Recalls & reported problems
Contego Medical, Inc. · The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. · Class 2
- 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 00851616007002), received between Mar 19, 2026 and Mar 19, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem1
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.
MalfunctionMar 19, 2026Activation Problem
EVENT DESCRIPTION: IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE LEFT CAROTID ARTERY USING THE PALADIN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IEP SYS, DIFFICULTY WAS NOTED DURING DEPLOYMENT. ARTERY DIAMETER REPORTED AS 4-6 MM. A NON-MEDTRONIC (SILK ROAD TCAR) SHEATH AND A 90 CM 014 NON-MEDTRONIC (SILK ROAD) GUIDEWIRE WERE USED. THE VESSEL WAS PRE-DILATED WITH A NON-MEDTRONIC (SILK ROAD TCAR) BALLOON. THE VESSEL WAS POST-DILATED WITH THE 5X30 MM PALADIN PTA IEP DEVICE. IT WAS REPORTED THAT THE THUMBWHEEL THAT OPENS AND CLOSES THE FILTER WAS NOT FUNCTIONING PROPERLY, AND THE PHYSICIAN WAS NOT ABLE TO FULLY DEPLOY THE FILTER. THE PHYSICIAN USED THE PALADIN BALLOON TO POST-DILATE THE LESION WITHOUT OPENING UP THE FILTER. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION: THE PRODUCT WAS NOT RETURNED, THEREFORE AN INVESTIGATION INTO THE ACTUAL PRODUCT COULD NOT BE PERFORMED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS CONDUCTED. NO MANUFACTURING DEVIATIONS, PROCESSING ANOMALIES, OR QUALITY ISSUES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED INABILITY TO DEPLOY THE FILTE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24636003 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.