Pacific™ Plus PCP060250150Recalls & reported problems
Medtronic, Inc. · CATH PCP060250150 PLUS US D6L250UL1500 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477072005), received between Feb 3, 2026 and Feb 3, 2026 — 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. 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
- 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.
MalfunctionFeb 3, 2026Burst Container or Vessel
IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING THE PACIFIC PLUS, THE BALLOON EXHIBITED A PIN HOLE BURST AT 6 ATM PRESSURE ON THE FIRST INFLATION. THE LESION WAS CHARACTERISED BY SEVERE CALCIFICATION, 60-80% STENOSIS, A LENGTH OF 200 MM, AND AN ARTERY DIAMETER OF 6.2-5.8 MM. THE PROCEDURE UTILIZED A 6FR NON MEDTRONIC SHEATH, SPIDER WIRE GUIDEWIRE, AND SPIDER EMBOLIC PROTECTION. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED WITH A NON MEDTRONIC DEVICE. INFLATION WAS PERFORMED WITH A NON MEDTRONIC INFLATION DEVICE USING 50/50 CONTRAST FLUID. THERE WAS NO RESISTANCE ENCOUNTERED DURING DEVICE ADVANCEMENT, AND THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE BALLOON DID NOT DETACH, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PACIFIC PLUS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247058 ↗
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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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