Encore™ 26 M001151050Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 08714729183624), received between Sep 20, 2017 and Mar 31, 2026 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (16 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 5, 2025Open, Classified

   The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

   Z-2533-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. AN ENCORE INFLATION DEVICE WAS SELECTED FOR USE. PACKAGING WAS DAMAGED DURING TRANSPORT. THE INNER POUCH WAS ALSO DAMAGED AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743766 ↗
• MalfunctionDec 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE BALLOON PRESSURE COULD NOT BE DETECTED. THE TARGET LESION WAS LOCATED ON THE CAROTID ARTERY. A ENCORE 26 MT SINGLE 15105 WAS SELECTED FOR CAROTID ARTERY STENOSIS PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE BALLOON PRESSURE COULD NOT BE DETECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872913 ↗
• MalfunctionDec 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. DURING RESTOCK, AN ENCORE 26 DEVICE WAS FOUND CONTAMINATED - WITH 2 HAIRS VISIBLE WITHIN THE SEALED, UNOPENED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT, AND THE DEVICE WAS NOT USED IN ANY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842377 ↗
• MalfunctionOct 31, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PACKAGING SEAL WAS COMPROMISED. AN ENCORE 26 PERIPHERAL INTERVENTION INFLATION DEVICE WAS SELECTED FOR USE. PRIOR PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER TEARS EASILY DUE TO THE BLISTER PACKAGE OF THE BOSTON SCIENTIFIC INFLATION PUMPS. THERE WAS NO VISIBLE DAMAGE TO THE OUTER PACKAGING, HOWEVER, A POTENTIAL RISK OF STERILITY BEING COMPROMISED DUE TO THE TORN PAPER LAYER THAT MAY HAVE COME INTO CONTACT WITH BOTH THE OUTER AND INNER SURFACES OF THE PACKAGING AND THE DEVICE ITSELF. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437178 ↗
• MalfunctionOct 29, 2025Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT A STERILITY ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR DEBULK PROCEDURE. PRIOR TO THE PROCEDURE, THE PACKAGING DID NOT OPEN PROPERLY, AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THE TEAR TAB REMAINED INTACT. NO ISSUES WERE NOTED WITH THE PACKAGING PRIOR TO OPENING, AND NO PHYSICAL DAMAGE WAS OBSERVED. THE DEVICE WAS NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415781 ↗
• MalfunctionOct 29, 2025Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT A STERILITY ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR DEBULK PROCEDURE. PRIOR TO THE PROCEDURE, THE PACKAGING DID NOT OPEN PROPERLY, AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THE TEAR TAB REMAINED INTACT. NO ISSUES WERE NOTED WITH THE PACKAGING PRIOR TO OPENING, AND NO PHYSICAL DAMAGE WAS OBSERVED. THE DEVICE WAS NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415775 ↗
• MalfunctionOct 24, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PACKAGING SEAL WAS COMPROMISED. THE TARGET LESION WAS LOCATED BELOW THE KNEE. AN ENCORE 26 PERIPHERAL INTERVENTION INFLATION DEVICE WAS SELECTED FOR USE. PRIOR PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER TEARS EASILY AND SOME PUMP WAS STICKING TO THE PLASTIC BLISTER. THERE WERE NO VISIBLE DAMAGE TO THE OUTER PACKAGING. HOWEVER, A POTENTIAL RISK OF STERILITY BEING COMPROMISED DUE TO THE TORN PAPER LAYER THAT MAY HAVE COME INTO CONTACT WITH BOTH THE OUTER AND INNER SURFACES OF THE PACKAGING AND THE DEVICE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381438 ↗
• MalfunctionOct 24, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PACKAGING SEAL WAS COMPROMISED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ENCORE 26 PERIPHERAL INTERVENTION INFLATION DEVICE WAS SELECTED FOR USE. PRIOR PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER TEARS EASILY AND SOME PUMP WAS STICKING TO THE PLASTIC BLISTER. THERE WERE NO VISIBLE DAMAGE TO THE OUTER PACKAGING. HOWEVER, A POTENTIAL RISK OF STERILITY BEING COMPROMISED DUE TO THE TORN PAPER LAYER THAT MAY HAVE COME INTO CONTACT WITH BOTH THE OUTER AND INNER SURFACES OF THE PACKAGING AND THE DEVICE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379258 ↗
• MalfunctionOct 24, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PACKAGING SEAL WAS COMPROMISED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ENCORE 26 PERIPHERAL INTERVENTION INFLATION DEVICE WAS SELECTED FOR USE. PRIOR PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER TEARS EASILY AND SOME PUMP WAS STICKING TO THE PLASTIC BLISTER. THERE WERE NO VISIBLE DAMAGE TO THE OUTER PACKAGING. HOWEVER, A POTENTIAL RISK OF STERILITY BEING COMPROMISED DUE TO THE TORN PAPER LAYER THAT MAY HAVE COME INTO CONTACT WITH BOTH THE OUTER AND INNER SURFACES OF THE PACKAGING AND THE DEVICE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379256 ↗
• MalfunctionOct 24, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PACKAGING SEAL WAS COMPROMISED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ENCORE 26 PERIPHERAL INTERVENTION INFLATION DEVICE WAS SELECTED FOR USE. PRIOR PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER TEARS EASILY AND SOME PUMP WAS STICKING TO THE PLASTIC BLISTER. THERE WERE NO VISIBLE DAMAGE TO THE OUTER PACKAGING. HOWEVER, A POTENTIAL RISK OF STERILITY BEING COMPROMISED DUE TO THE TORN PAPER LAYER THAT MAY HAVE COME INTO CONTACT WITH BOTH THE OUTER AND INNER SURFACES OF THE PACKAGING AND THE DEVICE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379255 ↗
• MalfunctionOct 24, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PACKAGING SEAL WAS COMPROMISED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ENCORE 26 PERIPHERAL INTERVENTION INFLATION DEVICE WAS SELECTED FOR USE. PRIOR PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER TEARS EASILY AND SOME PUMP WAS STICKING TO THE PLASTIC BLISTER. THERE WERE NO VISIBLE DAMAGE TO THE OUTER PACKAGING. HOWEVER, A POTENTIAL RISK OF STERILITY BEING COMPROMISED DUE TO THE TORN PAPER LAYER THAT MAY HAVE COME INTO CONTACT WITH BOTH THE OUTER AND INNER SURFACES OF THE PACKAGING AND THE DEVICE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379252 ↗
• MalfunctionOct 24, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PACKAGING SEAL WAS COMPROMISED. THE TARGET LESION WAS LOCATED BELOW THE KNEE. AN ENCORE 26 PERIPHERAL INTERVENTION INFLATION DEVICE WAS SELECTED FOR USE. PRIOR PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER TEARS EASILY AND SOME PUMP WAS STICKING TO THE PLASTIC BLISTER. THERE WERE NO VISIBLE DAMAGE TO THE OUTER PACKAGING. HOWEVER, A POTENTIAL RISK OF STERILITY BEING COMPROMISED DUE TO THE TORN PAPER LAYER THAT MAY HAVE COME INTO CONTACT WITH BOTH THE OUTER AND INNER SURFACES OF THE PACKAGING AND THE DEVICE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379251 ↗
• MalfunctionOct 24, 2025Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PACKAGING SEAL WAS COMPROMISED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ENCORE 26 PERIPHERAL INTERVENTION INFLATION DEVICE WAS SELECTED FOR USE. PRIOR PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER TEARS EASILY AND SOME PUMP WAS STICKING TO THE PLASTIC BLISTER. THERE WERE NO VISIBLE DAMAGE TO THE OUTER PACKAGING. HOWEVER, A POTENTIAL RISK OF STERILITY BEING COMPROMISED DUE TO THE TORN PAPER LAYER THAT MAY HAVE COME INTO CONTACT WITH BOTH THE OUTER AND INNER SURFACES OF THE PACKAGING AND THE DEVICE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379249 ↗
• MalfunctionOct 15, 2025Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A STERILITY ISSUE OCCURRED. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE DURING AN ENDOVASCULAR PROCEDURE. PRIOR TO PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE PAPER COVERING THE INNER TRAY OF THE DEVICE IS DIFFICULT TO TEAR. THERE WAS NO VISIBLE DAMAGING TO THE PACKAGING, HOWEVER THE STERILITY OF THE DEVICE WAS COMPROMISED. THE DEVICE WAS NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293600 ↗
• MalfunctionSep 16, 2025Defective Device; Output Problem

  FLUID NOTED IN TUBING.

  Patient problems: Insufficient Information

  MAUDE report 23061916 ↗
• MalfunctionJun 4, 2025Display or Visual Feedback Problem; Physical Resistance/Sticking; Display or Visual Feedback Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GAUGE WAS READING INACCURATELY, AND THE NEEDLE WAS STICKING. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, NON-CALCIFIED LATERAL CUTANEOUS VEIN. AN ENCORE PI INFLATION DEVICE WAS USED FOR TREATMENT. DURING THE PROCEDURE, THE BALLOON WAS INFLATED UNDER FLUOROSCOPY. HOWEVER, IT WAS NOTED THAT THE ENCORE METER DID NOT CHANGE FROM 0, THE GAUGE NEEDLE WAS STICKING AND DID NOT MOVE. DESPITE THE INACCURATE GAUGE READING AND NEEDLE STICKING, THE BALLOON ITSELF DID NOT FAIL TO INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146950 ↗
• MalfunctionMay 13, 2025Moisture Damage; Device Contamination with Chemical or Other Material

  UPON OPENING AN ENCORE 26 INFLATOR, IT WAS NOTED TO HAVE FLUID PRESENT IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008486 ↗
• MalfunctionJul 16, 2024Device Contamination with Chemical or Other Material; Material Integrity Problem; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND. A BOSTON SCIENTIFIC EMPLOYEE NOTED THAT THERE WAS A HAIR-LIKE OBJECT INSIDE THE UNOPENED INNER POUCH OF AN ENCORE 26 INFLATION DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756051 ↗
• MalfunctionDec 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE CONTAINED WHAT APPEARS TO BE A HAIR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410433 ↗
• MalfunctionNov 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. AN ENCORE 26 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT A HAIR WAS FOUND ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183102 ↗
• MalfunctionNov 15, 2023Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THERE IS A DROP OF WATER INSIDE THE TUBE. THE TARGET LESION WAS IN THE SHUNT LIMB. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USED. DURING PREPARATION, IT WAS NOTED THAT THERE IS A DROP OF WATER INSIDE THE TUBE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE IS NO PATIENT INJURY. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT A FOREIGN MATERIAL WAS FOUND INSIDE THE POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141633 ↗
• MalfunctionSep 22, 2023Contamination; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Contamination; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. AN ENCORE 26 WAS SELECTED FOR USE. DURING PREPARATION, DIFFICULTY OPENING AN ENCORE INFLATION SYRINGE WAS NOTED. WHILE ATTEMPTING TO OPEN THE PACKAGING, THE STERILE PAPER TORE AND CONTAMINATED THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804554 ↗
• MalfunctionSep 22, 2023Contamination; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Contamination; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. AN ENCORE 26 WAS SELECTED FOR USE. DURING PREPARATION, DIFFICULTY OPENING AN ENCORE INFLATION SYRINGE WAS NOTED. WHILE ATTEMPTING TO OPEN THE PACKAGING, THE STERILE PAPER TORE AND CONTAMINATED THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17802960 ↗
• MalfunctionJun 27, 2023Material Separation; Defective Device

  ENCORE 26 INFLATION DEVICE BEING USED DURING CASE APPEARS TO HAVE A DEFECT IN THE PLASTIC. SMALL ROUND AREA WAS NOTICED AFTER USING DEVICE. WAS NOT SURE IF PART OF PLASTIC CAME OFF INSIDE THE SYRINGE/TUBING PART OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208338 ↗
• MalfunctionMay 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN OBJECT IN THE DEVICE. AN ENCORE 26 INFLATION DEVICE WAS NOTED TO HAVE A WHITE FLOATING OBJECT INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872963 ↗