Pacific™ Plus PCP020120180Recalls & reported problems
Medtronic, Inc. · CATH PCP020120180 PCP D2.00 L 120 UL1800 · 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 08033477055602), received between Dec 13, 2023 and Dec 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
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.
MalfunctionDec 13, 2023Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE A PACIFIC PLUS PTA BALLOON DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS DISTAL POSTERIOR TIBIAL ARTERY. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED DURING REMOVAL OF THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING INFLATION AT 5ATMS. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. A REPLACEMENT PACIFIC PLUS PTA BALLOON WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18317100 ↗
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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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