Paladin 5.5x30Recalls & 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
Data updated Oct 13, 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 00851616007293), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Retraction 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
- Retraction 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 13, 2026Retraction Problem
EVENT DESCRIPTION A PALADIN PTA IEP SYS PD-5530-140-2 WAS ATTEMPTED TO BE USED BUT THE FILTER DIDN'T CLOSE ALL THE WAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 17TH FEB 2026 ADDITIONAL INFORMATION RECEIVED FROM THE REP: THE DEVICE DID NOT HAVE ANY FILTER PREP. EACH TIME THEY WOULD RETRACT THE DEVICE BACK AFTER THE FILTER WAS CLOSED IT WOULD START TO OPEN AGAIN. THEY WERE ABLE TO PULL BACK A LITTLE CLOSE THE FILTER MORE UNTIL THE DEVICE WAS BACK INSIDE OF THE GUIDE CATHETER WHERE IT WAS REMOVED SAFELY. INVESTIGATION: THE INVESTIGATION CONFIRMED THAT THE FILTER OPENED AND CLOSED NORMALLY. THERE IS A POTENTIAL THAT THE CATHETER WAS BEING STRETCHED DURING REMOVAL ACCOUNTING FOR THE FRAME OPENING. THE INVESTIGATION IS ONGOING. CONCLUSIONS THE FAILURE COULD NOT BE REPLICATED ON THE RETURNED UNIT. THE RETURNED UNIT OPENED AND CLOSED NORMALLY. THIS COMPLAINT WAS FELT TO BE CLINICALLY INSIGNIFICANT AND WOULD BE CONSIDERED VERY LOW RISK TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593708 ↗
Other Catheter, Angioplasty, Peripheral, Transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page