Pacific™ Plus PCP040100150Recalls & reported problems
Medtronic, Inc. · CATH PCP040100150 PLUS US D4L100UL1500 · Class 2
- 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 08033477072524), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
- 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.
InjuryAug 22, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE A PACIFIC PLUS PTA BALLOON DURING PERCUTANEOUS BALLOONING OF THE PATIENTS SUBCLAVIAN VEIN. THE ATTENDING PHYSICIAN INSERTED AND INFLATED THE PACIFIC PLUS .018 BALLOON, WHICH RUPTURED. THE PHYSICIAN REMOVED THE BALLOON CATHETER AND OBSERVED THAT THE TIP WAS MISSING. UNDER FLUOROSCOPY IT WAS CONFIRMED THAT THE RADIOPAQUE BAND FROM THE TIP OF THE BALLOON WAS RETAINED IN THE PATIENT. MULTIPLE ATTEMPTS WERE MADE WITH SNARES TO RETRIEVE THE BALLOON REMNANT, BUT THE TEAM WAS UNABLE TO RETRIEVE. PATIENT REMAINED STABLE THROUGHOUT PROCEDURE AND NO PATIENT HARM WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 20039976 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.