Pacific™ Plus PCP070040150Recalls & reported problems
Medtronic, Inc. · CATH PCP070040150 PLUS US D7L40UL1500 · 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 08033477072906), received between Nov 18, 2024 and Nov 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE A 2.5X60MM PACIFIC PLUS PTA BALLOON DURING TREATMENT OF THE PATIENT¿S COMMON ILIAC VEIN (CIV) & EXTERNAL ILIAC VEIN (EIV). THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATIONFLUID WAS USED. TRACKING DIFFICULTY DURING INITIAL ADVANCEMENT WAS REPORTED. MODERATE RESISTANCE WAS NOTED, OTHER BALLOON (BARD ATLAS) WAS UNABLE TO CROSS THE LESION. IT WAS REPORTED THAT THE 2.5X60MM PACIFIC PLUS BALLOON GOT STUCK ON AN 018 NON-MEDTRONIC WIRE AND WAS SAFELY REMOVED WITH THE WIRE FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO USE A 7X40MM PACIFIC PLUS PTA BALLOON. IT WAS REPORTED THAT THE 7X40MM PACIFIC PLUS GOT STUCK AND DETACHED AT THE TARGET LESION AS THEY TRIED TO REMOVE IT. ONLY A PARTIAL PIECE OF THE BALLOON WAS REMOVED. THE DETACHED COMPONENT WAS LEFT IN THE PATIENT. PHYSICIAN THEN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON TO PULL OUT THE DETACHED 7X40MM PACIFIC PLUS BUT THE NANOCROSS ELITE ALSO GOT STUCK AND DETACHED, THE NANOCROSS WAS REMOVED WITH A SNARE. THE DETACHED NANOCROSS ELITE WAS REMOVED FROM THE PATIENT. PROCEDURE WAS ABORTED. THE PATIENT MAY NEED SURGICAL INTERVENTION TO REMOVE T
Patient problems: Foreign Body In Patient
MAUDE report 20706732 ↗
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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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