Pacific™ Plus PCP040200200Recalls & reported problems
Medtronic, Inc. · CATH PCP040200200 PLUS US D4L200UL2000 · 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 08033477075228), received between Jul 9, 2025 and Jul 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Difficult to Advance1
- Difficult to Remove1
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.
MalfunctionJul 9, 2025Difficult to Remove; Defective Component; Difficult to Advance; Difficult to Remove; Defective Component; Difficult to Advance
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CATHETER PACIFIC PLUS, LOSS OF WIRE ACCESS OCCURRED WHEN THE GUIDEWIRE BECAME STUCK IN THE BALLOON WHILE TREATING A MODERATE, CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. HAD TO ABORT BALLOONING, AND ACCESS ACROSS THE LESION HAD TO BE RE-ESTABLISHED. A NEW PACIFIC PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (4MMX200MMX200MM) WAS USED TO COMPLETE THE PROCEDURE. THE RADIOPAQUE BALLOON MARKERS WERE REPORTEDLY MARKED INCORRECTLY, WITH DOUBLE MIDDLE MARKERS IN THE WRONG POSITION. TRACKING DIFFICULTY WAS NOTED DURING INITIAL ADVANCEMENT DUE TO AN ANCILLARY DEVICE, AND AFTER INFLATION, THERE WAS DIFFICULTY REMOVING THE BALLOON BECAUSE THE 0.018 GUIDEWIRE WAS STUCK INSIDE. THE BALLOON WAS SUCCESSFULLY REMOVED IN TANDEM WITHOUT INJURY OR INTERVENTION, AND THERE WAS NO VESSEL DAMAGE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND THE VESSEL WAS POST-DILATED WITH 50/50 CONTRAST AS THE INFLATION FLUID. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY, AND THE DEGREE OF TORTUOSITY WAS MINIMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459872 ↗
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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.
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