PACIFIC XTREME PCU060200130 (UDI 08033477058245)Recalls & reported problems
Medtronic, Inc. · CATH PCU060200130 PCU US 06 00L200UL1300 · Class 2
All models of PACIFIC XTREME (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 08033477058245), received between Dec 13, 2018 and Dec 13, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K103464); they may or may not involve this specific model.
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
- Detachment of Device or Device Component1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN INTENDED TO USE THE PACIFIC XTREME WITH A 6F NON-MEDTRONIC SHEATH A 014 NON-MEDTRONIC GUIDEWIRE AND A NON-MEDTRONIC I NFLATION DEVICE TO TREAT MODERATE STENOSIS IN THE POPLITEAL ARTERY. THE IFU WAS FOLLOWED AND THE DEVICE PREPPED WITH NO ISSUES IDENTIFIED. THE ARTERY DIAMETER WAS 6MM AND MODERATELY CALCIFIED LESION WAS 80MM. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT NO RESISTANCE OR EXCESSIVE FORCE WAS USED. THERE WAS NO INTERACTION BETWEEN THE BALLOON AND THE STENT. IT WAS REPORTED DURING TREATMENT OF AN IN-STENT RESTENOSIS THE BALLOON FRACTURED AND DETACHED DURING INFLATION IN THE PATIENT'S POPLITEAL ARTERY. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE LEAVING THE DETACHED SEGMENT OF BALLOON IN THE PATIENT. A PROTÉGÉ EVERFLEX WAS USED TO CAGE THE BALLOON.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8159542 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103464. One submission often covers many models, so check the product and lot details in each record.
- Z-3055-2020 · Aug 26, 2020 · TerminatedPacific Xtreme (PTCA Balloon Dilation Catheter)
Other CATHETER, PERCUTANEOUS devices
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- 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.
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