Pacific™ Plus PCP040150150Recalls & reported problems
Medtronic, Inc. · CATH PCP040150150 PLUS US D4L150UL1500 · 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 08033477072562), received between Jan 16, 2025 and Jan 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation 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
- Deflation Problem1
- Inflation 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.
MalfunctionJan 16, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
IT WAS REPORTED THAT THERE WERE DEFLATION AND INFLATION DIFFICULTIES WITH THE CATHETER PACIFIC PLUS DURING A PROCEDURE INVOLVING THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE BALLOON TOOK LONGER THAN USUAL TO DEFLATE AND WAS REPOSITIONED AND RE-INFLATED WITH SOME DIFFICULTY. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL AFTER WAITING FOR IT TO DEFLATE ON ITS OWN. THE PROCEDURE WAS COMPLETED AFTER THE SECOND DEFLATION WAS COMPLETED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT ON THE PATIENT, AND THE DEVICE WAS SAFELY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21166105 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.