Pacific™ Plus PCP060200150Recalls & reported problems
Medtronic, Inc. · CATH PCP060200150 PLUS US D6L200UL1500 · 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 08033477072883), received between Sep 8, 2025 and Sep 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation 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
- Inflation Problem1
- Leak/Splash1
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 8, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY INTERVENTION INVOLVING THE CATHETER PACIFIC PLUS BALLOON, A PATIENT WAS TREATED FOR A CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION EXHIBITED 100% STENOSIS, MEASURED 150 MM IN LENGTH, AND HAD A MODERATE DEGREE OF CALCIFICATION. INFLATION DIFFICULTIES WERE ENCOUNTERED WITH THE REPORTED CATHETER DEVICE, AND A LEAK WAS NOTED ON THE SHAFT. THE DEVICE FUNCTIONED DURING VESSEL PREPARATION BUT WOULD NOT INFLATE TO POST-DILATE AFTER STENT PLACEMENT (MEDTRONIC EVERFLEX PRB35-06-200-120 AND MEDTRONIC EVERFLEX EVD35-06-150-120). THE VESSEL WAS PRE-DILATED USING THE SAME DEVICE AND POST-DILATED WITH A MEDTRONIC ADMIRAL XTREME 6 X 250 X 130 CM AFTER THE REPORTED DEVICE FAILED TO INFLATE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO DAMAGE NOTED TO THE STENTS. THE PHYSICIAN EXPERIENCE A LOT OF RESISTANCE THROUGHOUT THE PROCEDURE PARTICULARLY WHEN WITHDRAWING THE BALLOON FROM THE PATIENT INTO THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991589 ↗
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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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