Pacific™ Plus PCP025120130Recalls & reported problems
Medtronic, Inc. · CATH PCP025120130 PCP D2.50 L 120UL1300 · 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 08033477055053), received between Sep 13, 2021 and Sep 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device 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.
Most reported problems
Device problems
- Use of Device 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.
MalfunctionSep 13, 2021Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PHYSICIAN USED AND EXPIRED PACIFIC BALLOON DURING PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. PHYSICIAN WANTED TO KNOW IS THERE ANY RISK TO THE PATIENT USING AN EXPIRED BALLOON DURING PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NOTICED THE EXPIRATION DATE WHEN DOING PROCEDURE CHARGES. PATIENT STATUS AT TIME OF THE REPORT WAS ASKED BUT UNKNOWN. THERE WAS NO INTERVENTION NEEDED DUE TO THE USE OF AN EXPIRED BALLOON. THERE WAS NO PATIENT INJURY. THE STATUS OF THE PATIENT IS OKAY WITH NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12458777 ↗
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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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