Caterpillar CTP027015URecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741155307), received between Jul 16, 2020 and Jun 27, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (4 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING AN ARTERIAL EMBOLIZATION DEVICE PLACEMENT PROCEDURE, THE PLUG ALLEGEDLY PREMATURELY DEPLOYED IN THE SEALED PACKET. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14825551 ↗
• MalfunctionJul 23, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING PLACEMENT OF AN ARTERIAL EMBOLIZATION DEVICE, THE STUDY DEVICE WAS FAILURE TO ADVANCE. THE DEVICE COULD NOT ADVANCE THROUGH THE CATHETER. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217012 ↗
• InjuryMay 24, 2021Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING PLACEMENT OF AN ARTERIAL EMBOLIZATION DEVICE, THE STUDY DEVICE HAD POOR VISIBILITY UNDER FLUOROSCOPY. THE DEVICE WAS ACCURATELY DEPLOYED AT THE TARGET EMBOLIZATION SITE WITHOUT MIGRATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869436 ↗
• MalfunctionFeb 2, 2021Poor Quality Image; Failure to Advance; Device-Device Incompatibility; Premature Separation; Poor Quality Image; Failure to Advance; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING PLACEMENT OF AN ARTERIAL EMBOLIZATION DEVICE, THE STUDY DEVICE WAS DIFFICULT TO ADVANCE AND WAS NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE DEVICE APPEARED DETACHED PREMATURELY, UNABLE TO BE VISUALIZED UNDER FLUOROSCOPY AND DEVICE INCOMPATIBILITY. THE PATIENT WAS SUCCESSFULLY TREATED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11264707 ↗
• MalfunctionDec 1, 2020Difficult or Delayed Positioning; Leak/Splash; Poor Quality Image; Difficult to Advance; Difficult or Delayed Positioning; Leak/Splash; Poor Quality Image; Difficult to Advance

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING PLACEMENT OF AN ARTERIAL EMBOLIZATION DEVICE, IT WAS DIFFICULT TO TRACK/DELIVER THE DEVICE TO THE TARGET EMBOLIZATION SITE, AND THE DEVICE VISIBILITY UNDER FLUOROSCOPY WAS NOT ACCEPTABLE. IT WAS FURTHER REPORTED THERE WAS INCOMPLETE OCCLUSION OF THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10927044 ↗
• MalfunctionNov 30, 2020Leak/Splash; Poor Quality Image; Leak/Splash; Poor Quality Image

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT DURING PLACEMENT OF AN ARTERIAL EMBOLIZATION DEVICE, THE STUDY DEVICE WAS DIFFICULT / UNABLE TO BE VISUALIZED UNDER FLUOROSCOPY. THE DEVICE WAS ACCURATELY DEPLOYED AT THE TARGET EMBOLIZATION SITE WITHOUT MIGRATION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS INEFFICIENT/SLOW TO OCCLUDE THE TARGET SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10918199 ↗
• MalfunctionOct 30, 2020Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CTP027015U ARTERIAL EMBOLIZATION DEVICE ALLEGEDLY EXPERIENCED PEELED/DELAMINATED MATERIAL AND FAILURE TO ADVANCE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763147 ↗
• MalfunctionJul 16, 2020Material Perforation; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CTP027015U EMBOLIZATION SYSTEM ALLEGEDLY EXPERIENCED MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD PATIENT INVOLVEMENT BUT THE PATIENT HAD NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283321 ↗