Pacific™ Plus PCP040300150Recalls & reported problems
Medtronic, Inc. · CATH PCP040300150 PLUS US D4L300UL1500 · 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 08033477072159), received between May 27, 2025 and May 27, 2025 — 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. How this data works · Data updated Oct 13, 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.
MalfunctionMay 27, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE CATHETER PCP040300150 PACIFIC PLUS US D4L300UL1500, A BALLOON BURST OCCURRED ON THE FIRST INFLATION. A 7X45 NON-MEDTRONIC SHEATH AND A 014X300CM NITREX GUIDEWIRE WERE USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST. EMBOLIC PROTECTION WAS NOT USED AND THE VESSEL WAS NOT PRE-OR POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE EVENT TOOK PLACE IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, WHICH WERE IDENTIFIED AS CALCIFIED TARGET LESIONS. THE BALLOON BURST WAS NOTED DURING THE PROCEDURE, THE TYPE OF BALLOON BURST AND PRESSURE IT BURST AT IS UNKNOWN. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THERE WAS NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, SPECIFICALLY A TURBOHAWK PLUS LX. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22087141 ↗
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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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