In.Pact™ 018 IPU04015013PRecalls & reported problems
Medtronic, Inc. · DCB 018 IPU04015013P D4.0 L150 UL0130 · Class 3
Data updated Oct 18, 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 00763000291303), received between May 13, 2026 and May 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
1 other recall cover devices cleared under the same FDA submission (P140010); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
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 13, 2026Leak/Splash
IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE INVOLVING THE IN.PACT 018 DRUG COATED BALLOON IN THE DISTAL SUPERFICIAL FEMORAL ARTERY, A BALLOON LEAK WAS NOTED DURING THE PROCEDURE. MINIMAL TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. THE BALLOON WAS INFLATED USING A SYRINGE WITH 50/50 CONTRAST. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE (.018 6MM INPACT ADMIRAL). NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159006 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140010. One submission often covers many models, so check the product and lot details in each record.
- Z-1042-2022 · Mar 23, 2022 · Open, ClassifiedMedtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM040120
Other Drug-Eluting Peripheral Transluminal Angioplasty Catheter devices
- LUTONIX® Drug Coated Balloon LX351305150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter117 reports
- LUTONIX® Drug Coated Balloon LX351306150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter75 reports
- Ranger™ H74939419502010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Ranger™ H74939419602010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Lutonix® Drug Coated Balloon LX351305100Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter66 reports
- IN.PACT™ Admiral™ ADM06004013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall12 reports
- IN.PACT™ Admiral™ ADM06015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall11 reports
- IN.PACT™ Admiral™ ADM04015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall8 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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