Encore 26Recalls & reported problems across all models

We found 4 models of Encore 26 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between May 18, 2017 and Sep 14, 2026 — classified as 2 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (37 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Encore 26 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 4 of these models · Recall details · FDA record ↗

Most reported Encore 26 problems

Encore 26 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Encore™ 26 M001151050

  Syringe, balloon inflation
  1 recall54 reports
• Encore 26 M00566670

  Syringe, Balloon Inflation, Exempt
  1 recall26 reports
• Encore™ 26 H74904526011

  Syringe, balloon inflation
  1 recall25 reports
• Encore 26 M0067101140

  Syringe, Balloon Inflation, Exempt
  1 recall8 reports

Recent Encore 26 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Display or Visual Feedback Problem

  It was reported that Encore was to be used in a procedure. During procedure, the pressure was not registered when the balloon was inflated. There were no patient complications reported. No further information was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755254 ↗
• MalfunctionSep 14, 2026Display or Visual Feedback Problem

  It was reported to Boston Scientific Corporation that an Encore 26 Inflation Device was being prepared to be used in the Common Bile Duct (CBD) during an Endoscopic retrograde cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During preparation, the gauge barometer failed. The procedure was completed with another Encore 26 Inflation Device.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754002 ↗
• MalfunctionSep 14, 2026Display or Visual Feedback Problem

  It was reported to Boston Scientific Corporation that an Encore 26 Inflation Device was being prepared to be used in the Common Bile Duct (CBD) during an Endoscopic retrograde cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During preparation, the gauge barometer failed. The procedure was completed with another Encore 26 Inflation Device.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748342 ↗
• MalfunctionJul 13, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE BAROMETER MALFUNCTIONED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807882 ↗
• MalfunctionJul 12, 2026Display or Visual Feedback Problem

  It was reported to Boston Scientific Corporation that an Encore 26 inflation device was attempted to be used in the common bile duct during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6)2026.During preparation outside of the patient, the barometer malfunctioned. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be good.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25790409 ↗
• 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 ↗
• MalfunctionFeb 16, 2026Display or Visual Feedback Problem; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GAUGE READS INACCURATELY. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING THE ANGIOPLASTY PROCEDURE, THE INFLATION SYRINGE MALFUNCTIONED, THE GAUGE NEEDLE FAILED TO DISPLAY THE APPROPRIATE PRESSURE AND REMAINED STUCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24348563 ↗
• MalfunctionFeb 3, 2026Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DIFFICULT TO MAINTAIN STERILITY. THE PATIENT PRESENTED WITH ANGINA AND REQUIRED CALCIUM PREPARATION. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). PRIOR TO THE PROCEDURE, THE PACKAGING OF THE ENCORE MANOMETERS WAS DIFFICULT TO OPEN AND TENDED TO TEAR AT THE CORNER, CAUSING THE PAPER TO FLARE AND MAKING IT CHALLENGING TO MAINTAIN STERILITY. DESPITE THIS PACKAGING ISSUE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247301 ↗
• MalfunctionJan 27, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATTER WAS PRESENT IN THE DEVICE. AN ENCORE 26 SINGLE 0452601 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MANIFOLD SYRINGE USED HAD A LOT OF PLASTIC PIECES THAT CAME OUT FROM INSIDE THE ENCORE PACKAGING. THERE WAS NO DAMAGE NOTICED WITH THE DEVICE, AND THE PIECES DID NOT APPEAR TO COME FROM THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191030 ↗
• MalfunctionJan 14, 2026Display or Visual Feedback Problem; Inflation Problem

  IT WAS REPORTED THAT A GAUGE ISSUE OCCURRED. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GAUGE DID NOT RISE, SO THE PRESSURE COULD NOT BE MEASURED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067364 ↗
• 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 ↗

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