Encore™ 26 Advantage Kit H74904527011Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729180005), received between Mar 27, 2019 and Sep 25, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (6 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. How this data works · Data updated Oct 13, 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-2534-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Contaminated During Manufacture or Shipping

  It was reported that foreign material was present in the device.An Encore 26 Advantage Kit was selected for use. During unpacking, a strand of hair was found inside the packaging. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893282 ↗
• MalfunctionJul 10, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A FOREIGN MATTER WAS PRESENT ON THE PACKAGING. AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. AT THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THERE WAS HAIR INSIDE THE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786384 ↗
• MalfunctionFeb 18, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATTER WAS PRESENT IN THE DEVICE. AN ENCORE IC WAS SELECTED FOR US. DURING PREPARATION, WHILE REMOVING THE DEVICE FROM ITS SECONDARY PACKAGING AND BEFORE OPENING THE PRIMARY PACKAGING, A STRAND OF HAIR WAS OBSERVED INSIDE THE PRIMARY PACKAGING. THE DEVICE WAS NOT USED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379302 ↗
• MalfunctionFeb 2, 2026Deflation Problem; Display or Visual Feedback Problem; Failure to Deflate

  IT WAS REPORTED THAT THE GAUGE READING WAS INACCURATE. IT WAS NOTED THAT TWO ENCORE DEVICES DID NOT INFLATE OR DEFLATE THE BALLOON APPROPRIATELY, CAUSING TWO BALLOONS TO RUPTURE. THE DIAL DOES NOT SEEM TO REFLECT THE CORRECT ATMOSPHERES WHEN BEING UTILIZED AND THE RELEASE BUTTON WAS INCORRECT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232975 ↗
• MalfunctionFeb 2, 2026Deflation Problem; Display or Visual Feedback Problem; Inflation Problem

  IT WAS REPORTED THAT THE GAUGE READING WAS INACCURATE. IT WAS NOTED THAT TWO ENCORE DEVICES DID NOT INFLATE OR DEFLATE THE BALLOON APPROPRIATELY, CAUSING TWO BALLOONS TO RUPTURE. THE DIAL DOES NOT SEEM TO REFLECT THE CORRECT ATMOSPHERES WHEN BEING UTILIZED AND THE RELEASE BUTTON WAS INCORRECT. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THIS EVENT IS A DUPLICATE OF EMDR 2124215-2026-05711.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232969 ↗
• MalfunctionFeb 2, 2026Deflation Problem; Display or Visual Feedback Problem; Inflation Problem

  IT WAS REPORTED THAT THE GAUGE READING WAS INACCURATE. IT WAS NOTED THAT TWO ENCORE DEVICES DID NOT INFLATE OR DEFLATE THE BALLOON APPROPRIATELY, CAUSING TWO BALLOONS TO RUPTURE. THE DIAL DOES NOT SEEM TO REFLECT THE CORRECT ATMOSPHERES WHEN BEING UTILIZED AND THE RELEASE BUTTON WAS INCORRECT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232613 ↗
• MalfunctionFeb 2, 2026Deflation Problem; Display or Visual Feedback Problem; Inflation Problem

  IT WAS REPORTED THAT THE GAUGE READING WAS INACCURATE. IT WAS NOTED THAT TWO ENCORE DEVICES DID NOT INFLATE OR DEFLATE THE BALLOON APPROPRIATELY, CAUSING TWO BALLOONS TO RUPTURE. THE DIAL DOES NOT SEEM TO REFLECT THE CORRECT ATMOSPHERES WHEN BEING UTILIZED AND THE RELEASE BUTTON WAS INCORRECT. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THIS EVENT IS A DUPLICATE OF EMDR 2124215-2026-05709.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232563 ↗
• MalfunctionJul 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PACKAGING CONTAINS A FOREIGN OBJECT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERY. AN ENCORE ADVANTAGE 26 0452701 WAS SELECTED FOR SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING PREPARATION, IT WAS NOTED THAT THE INNER PACKAGING CONTAINS A FOREIGN OBJECT. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572334 ↗
• MalfunctionMar 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT GAUGE INACCURACY OCCURRED. THE 90% TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ARTERY. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO EXTEND THE BALLOON CATHETER TO NOMINAL PRESSURE, HOWEVER THE GAUGE WOULD NOT GO UP. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691083 ↗
• MalfunctionFeb 5, 2025

  IN CATHLAB - EQUIPMENT (INDEFLATOR) USED DURING CATH LAB PROCEDURE WAS FOUND TO HAVE DEBRIS FLOATING INSIDE CYLINDER. CYLINDER IS FILLED WITH A MIX OF SALINE AND CONTRAST, WHICH DID NOT CONTAIN THIS DEBRIS. TWO INDEFLATORS WERE USED AND THEY BOTH HELD DEBRIS WHICH WAS BLACK AND WHITE. THE EQUIPMENT HAD THE SAME LOT NUMBER. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312220 ↗
• MalfunctionJan 31, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS OBSERVED ON THE DEVICE. FOLLOWING OPENING OF THE PACKAGE, A BLACK HAIR WAS NOTED ON THE ENCORE 26 LOCKING BUTTON. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619446 ↗
• MalfunctionDec 19, 2023Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE GAUGE NEEDLE OF THE INDEFLATOR HAS BEEN SHAKEN OFF. A 26 0452701 ADVANTAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GAUGE NEEDLE HAS BEEN SHAKEN OFF AND DID NOT RETURN TO ITS ORIGINAL STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE NEEDLE WAS UNABLE TO BE RETURNED TO ZERO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357765 ↗
• MalfunctionDec 19, 2023Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE GAUGE NEEDLE OF THE INDEFLATOR HAS BEEN SHAKEN OFF. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GAUGE NEEDLE HAS BEEN SHAKEN OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GAUGE NEEDLE WAS UNABLE TO BE RETURNED TO ZERO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357220 ↗
• MalfunctionDec 8, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PRESSURE GAUGE ISSUE OCCURRED. AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER INFLATION, THE ATMOSPHERE MARKER MALFUNCTIONED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290452 ↗
• MalfunctionDec 4, 2023Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30NOV2023. IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED. AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE INFLATOR WAS UNABLE TO FUNCTION PROPERLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE GAUGE COULD NOT ZERO. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THE GAUGE NEEDLE WAS AT 10 ATM WHEN RECEIVED AND WAS UNABLE TO BE RETURNED TO 0. THE DEVICE PRESENTED A CONTRAST MEDIA IN THE TUBE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DEVICE WAS UNABLE TO BE RETURNED TO 0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18261099 ↗
• MalfunctionSep 21, 2023Failure to Zero; Failure to Zero

  IT WAS REPORTED THAT THE DEVICE NEEDLE TURNED FULLY WHEN DEFLATED. AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING DEFLATION, IT WAS NOTED THAT THE NEEDLE METER TURNS FULLY WHEN DEFLATED AND WOULD NOT RETURN BACK TO ZERO. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17792855 ↗
• MalfunctionJan 23, 2023Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05JAN2023. IT WAS REPORTED THAT DEVICE WAS UNABLE TO INFLATE, AND NO PRESSURE WAS ACHIEVED. AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE INDEFLATOR WAS CONNECTED TO A BALLOON CATHETER AND ATTEMPTED INFLATION BY TURNING THE HANDLE IN ORDER TO PERFORM DILATATION, HOWEVER, THE BALLOON DID NOT INFLATE. THE METER OF THE INDEFLATOR DID NOT MOVE EITHER; THEREFORE, THE HANDLE OF THE INDEFLATOR WAS TURNED FURTHER, AND THE METER MOVED UP TO 26ATM AND WAS ABLE TO SWING OUT. THE USED OF THE DEVICE WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE GAUGE NEEDLE FAILED TO ZERO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229543 ↗
• MalfunctionOct 27, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11 OCT 2022. IT WAS REPORTED THAT THERE WAS AN ABNORMALITY ON THE METER OF THE INDEFLATOR. A ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT AN ABNORMALITY ON THE METER OF THE INDEFLATOR WAS OBSERVED DURING BALLOON CATHETER INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GAUGE DID NOT RETURN TO ZERO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15687550 ↗
• MalfunctionOct 6, 2022Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14SEP2022. IT WAS REPORTED THAT THE PRESSURE LOST, AND MANOMETER WAS DYSFUNCTIONAL. AN ENCORE 26 ADVANTAGE KIT INFLATION DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PRESSURE WAS LOST, AND THE MANOMETER WAS DYSFUNCTIONAL. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GAUGE ACCURACY TEST WAS NOT ABLE TO COMPLETE DUE TO LOSS OF THE NEEDLE TO ZERO LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551286 ↗
• MalfunctionSep 16, 2022Display or Visual Feedback Problem; Inflation Problem; Display or Visual Feedback Problem; Inflation Problem

  IT WAS REPORTED THAT THE GAUGE NEEDLE DID NOT SHOW THE PROPER PRESSURE. AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GAUGE NEEDLE DID NOT SHOW THE PROPER PRESSURE. SUBSEQUENTLY, THE GAUGE MOVED UP TO 26 ATMOSPHERES WHEN THE HANDLE OF THE INDEFLATOR WAS TURNED AND IT WAS SHAKEN OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438830 ↗
• MalfunctionAug 3, 2022Failure to Zero; Failure to Zero

  IT WAS REPORTED THAT THE PRESSURE DID NOT RETURN TO THE INITIAL PRESSURE (0 ATM). A ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INFLATED AT 26 ATM. UPON DEFLATION, THE BALLOON WAS IN NEGATIVE PRESSURE, HOWEVER, THE MANOMETER REMAINED AT A PRESSURE OF 26 ATM AND DID NOT RETURN TO THE INITIAL PRESSURE OF 0 ATM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160329 ↗
• MalfunctionAug 3, 2022Failure to Zero; Failure to Zero

  IT WAS REPORTED THAT THE PRESSURE DID NOT RETURN TO THE INITIAL PRESSURE (0 ATM). AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INFLATED AT 26 ATM. UPON DEFLATION, THE BALLOON WAS IN NEGATIVE PRESSURE, HOWEVER, THE MANOMETER REMAINED AT A PRESSURE OF 26 ATM AND DID NOT RETURN TO THE INITIAL PRESSURE OF 0 ATM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160282 ↗
• MalfunctionNov 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GAUGE NEEDLE DID NOT MOVE DOWN. AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE METER PART OF THE INDEFLATOR WAS UNUSUAL AS THE GAUGE NEEDLE DID NOT MOVE DOWN WHEN DEFLATION WAS PERFORMED AFTER PRESSURE WAS APPLIED TO 24 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752413 ↗
• MalfunctionOct 13, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND. A HAIR WAS NOTED TO BE SEALED INSIDE THE UNOPENED STERILE PACKAGING OF AN ENCORE 26 ADVANTAGE INFLATION DEVICE. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623689 ↗
• MalfunctionAug 30, 2021Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. AN ENCORE 26 ADVANTAGE KIT WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE DEVICE WAS USED TO INFLATE THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOONS. DURING POST DILATATION, SMALL METALLIC PARTICLES WERE FOUND AFTER THE CHAMBER WAS FILLED. CONTRAST AND HEPARINIZED SALINE WAS ADDED. THE SOURCE OF THE PARTICLES IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384210 ↗