Pacific™ Plus PCP070100150Recalls & reported problems
Medtronic, Inc. · CATH PCP070100150 PLUS US D7L100UL1500 · Class 2
All models of Pacific Plus (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477072982), received between Mar 10, 2025 and Mar 10, 2025 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation 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.
InjuryMar 10, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A PACIFIC PLUS, THERE WERE DEFLATION DIFFICULTIES WITH THE BALLOON CATHETER IN THE RIGHT MID COMMON FEMORAL ARTERY. THE TARGET LESION WAS IDENTIFIED AS CALCIFIED WITH MODERATE CALCIFICATION AND TORTUOSITY. ARTERY DIAMETER REPORTED AS 6-7MM AND LESION DIAMETER REPORTED AS 80MM. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. THE PATIENT EXPERIENCED A 15-MINUTE DELAY IN SURGERY DUE TO THE PRODUCT MALFUNCTION. THE BALLOON WAS EVENTUALLY DEFLATED MANUALLY WITH A NEEDLE STICK AFTER 15 MINUTES OF NEGATIVE PRESSURE, USING ULTRASOUND GUIDANCE INTO THE RIGHT GROIN WHERE THE BALLOON WAS STUCK INFLATED. THE PROCEDURE WAS COMPLETED USING A NEW 7X80 IN.PACT 018 DRUG COATED BALLOON. THE PATIENT RECOVERED AND WAS EXPOSED TO UNNECESSARY RISK ASSOCIATED WITH ADDITIONAL VESSEL TRAUMA. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21558019 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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