Pacific™ Plus PCP030020180Recalls & reported problems
Medtronic, Inc. · CATH PCP030020180 PCP D3.00 L 20 UL 1800 · 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 08033477055121), received between Apr 19, 2021 and Apr 19, 2021 — 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.
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.
MalfunctionApr 19, 2021Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 10MM CALCIFIED LESION IN THE PATIENT¿S MID RIGHT ANTERIOR TIBIAL ARTERY OF REPORTED DIAMETER 3MM. MODERATE VESSEL CALCIFICATION IS REPORTED. LESION EXHIBITED 90% STENOSIS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED SEVERE RESISTANCE WAS NOTED DURING INITIAL ADVANCEMENT AND THE DEVICE WAS UNABLE TO CROSS. THE DEVICE WAS REMOVED, AND PRE-DILATION WAS PERFORMED USING A PACIFIC PLUS PTA BALLOON WHICH WAS PREPPED AS PER IFU WITHOUT ISSUE. AN INFLATION DEVICE WAS USED WITH 50/50 SALINE CONTRAST SOLUTION FOR BALLOON INFLATION. NO RESISTANCE WAS NOTED DURING ADVANCEMENT AND THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE HAWKONE DEVICE WAS REINSERTED AND 3-4 PASSES WERE MADE. WHILE ATTEMPTING TO REMOVE THE HAWK, RESISTANCE WAS FELT WHEN DEVICE WAS IN SHEATH. WHEN HAWK WAS PULLED OUT, IT WAS OBSERVED THAT THE MEC WAS MISSING. UNDER FLUORO THE MEC WAS SEEN INSIDE THE SHEATH. THE WIRE WAS REMOVED AND THE ENTIRE MEC WAS REMOVED. IT WAS OBSERVED THAT THE WIRE WAS LOOPED AROUND THE MEC. ANOTHER WIRE DELIV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11684417 ↗
Other CATHETER, PERCUTANEOUS devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page