Encore™ 26 H74904526011Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729177029), received between Oct 8, 2018 and Feb 16, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (8 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, 2025Class IIOpen, 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 25 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionOct 30, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT GAUGE INACCURACY OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED SHUNT. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. IT WAS NOTED THAT THE BALLOON INFLATED, HOWEVER, THE PRESSURE GAUGE ONLY REACHED 25 ATMOSPHERES. IT DID NOT INCREASE UP TO 26 ATMOSPHERES WHEN MORE PRESSURE WAS APPLIED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571144 ↗
• MalfunctionApr 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE GAUGE READS INACCURATELY. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GAUGE NEEDLE DID NOT DISPLAY THE APPROPRIATE PRESSURE AND IT WAS UNABLE TO INCREASE. 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 19029844 ↗
• MalfunctionDec 22, 2023Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE GAUGE WAS SHOWING INCORRECT PRESSURE. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. THE ENCORE DEVICE INFLATED THE BALLOON EVEN THOUGH THE PRESSURE GAUGE NEEDLE DID NOT MOVE. ADDITIONALLY, A LOOSE JINGLING SOUND WAS HEARD WHEN THE INDEFLATOR WAS MOVED WHICH MAY INDICATE THAT THERE IS A BROKEN PART WITHIN. 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 18389169 ↗
• MalfunctionJul 26, 2023Contamination; Contamination

  IT WAS REPORTED THAT A HAIR WAS PRESENT ON THE PRESSURE PUMP GAUGE. A ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THERE WAS A HAIR ATTACHED TO THE PRESSURE PUMP GAUGE. THE DEVICE WAS CONSIDERED CONTAMINATED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17399142 ↗
• MalfunctionMay 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING PREPARATION, A FOREIGN MATERIAL WAS FOUND INSIDE THE COVER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915661 ↗
• MalfunctionOct 24, 2022Inflation Problem; Leak/Splash; Connection Problem; Inflation Problem; Leak/Splash; Connection Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11OCT2022. IT WAS REPORTED THAT THE DEVICE COULD NOT INFLATE. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING PREPARATION, WHEN CONNECTING THE DEVICE TO THE BALLOON, AN INFLATION ISSUE WAS NOTED. THERE WAS A LEAK OBSERVED IN THE HUB LUER AREA. THE DEVICE WAS REPLACED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE NEEDLE FAILED TO ZERO BETWEEN 0 ATM AND 26 ATM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660578 ↗
• MalfunctionOct 7, 2022Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE AIR PRESSURE DID NOT RISE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. AN ENCORE 26 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE AIR PRESSURE DOES NOT RISE DURING THE PROCESS OF EXPANDING THE LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT WHEN THE PLUNGER HANDLE WAS ROTATED THE NEEDLE DID NOT RETURN TO ZERO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15558115 ↗
• MalfunctionOct 3, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT A FOREIGN MATTER ADHERED INSIDE THE STERILE COVER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15531963 ↗
• MalfunctionDec 28, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE GAUGE NEEDLE WOULD NOT GO UP. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE GAUGE NEEDLE WAS STRANGE AS IT WOULD NOT GO UP EVEN IF THE BALLOON WAS INFLATING. 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 13101625 ↗
• InjuryJul 16, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE ON THE ANGIOPLASTY OF THE LEFT MAIN ARTERY. DURING THE PROCEDURE, THE INFLATION DEVICE HAD DIFFICULTY IN INFLATING THE BALLOON AND RELEASING THE STENT. THEN, WHEN THE BALLOON WAS FINALLY INFLATED INTO THE TARGET LESION, THE DEFLATION BUTTON HARDENED AND WOULD NOT ALLOW DEFLATION. IT HAD TO BE HIT IN ORDER TO RESPOND. AFTER HITTING, THE BALLOON WAS FINALLY ABLE TO DEFLATE AND WAS COMPLETELY REMOVED. IT WAS NOTED THAT THE PATIENT EXPERIENCED TRANSITORY HYPOTENSION DUE TO THE DEFLATION ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 12182177 ↗
• MalfunctionNov 5, 2020Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. IT WAS REPORTED THAT THE DEVICE KEPT ON SLIPPING OFF THE DELIVERY SYSTEM. DURING ANGIGRAM PROCEDURE, AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE AND WAS SCREWED ONTO THE STENT DELIVERY SYSTEM. HOWEVER, IT KEPT ON SLIPPING OFF THE DELIVERY SYSTEM AND UNABLE THE ACTION TO BE PULLED TO NEGATIVE. THE PHYSICIAN TRIED TO DO THE SAME PROCESS COUPLE OF TIMES BUT DEVICE KEPT ON SLIPPING OFF. IT WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND USED ONTO THE SAME STENT, WHICH WORKED PERFECTLY. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS IN NORMAL CONDITION AFTER THE PROCEDURE. HOWEVER, DEVICE INVESTIGATION REVEALED THAT THE GAUGE WAS NOT READING AND THE NEEDLE REMAINED IN THE POSITION OF 0 ATM THOUGH THE UNIT WAS PRESSURIZED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791216 ↗
• MalfunctionMar 11, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN OBJECT ON THE DEVICE. DURING UNPACKING OF AN ENCORE 26 INFLATION DEVICE, IT WAS NOTED THAT THERE WAS A FOREIGN OBJECT AND CONTAMINANT ON THE INNER WALL OF THE TUBE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9819276 ↗
• MalfunctionMar 11, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A GAUGE MALFUNCTION OCCURRED. DURING PREPARATION OF AN ENCORE 26 INFLATION DEVICE, PRESSURE WENT UP BUT THE GAUGE DID NOT MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818553 ↗
• MalfunctionFeb 5, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE OPENING SEAL FLAP PART WAS TORN OFF. A ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. IT WAS NOTED THAT THE OPENING SEAL WAS NOT PEELED OF, BUT THE FLAP PART WAS TORN OFF INDICATING THAT THE SEAL OF THE PRODUCT BOX WAS FOUND TO BE DAMAGED. NO COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9672898 ↗
• MalfunctionNov 21, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN INACCURATE GAUGE READING OCCURRED. AN ENCORE 26 WAS SELECTED FOR USE. UPON PREPARATION, IT WAS NOTED THAT THE GAUGE MEMORY WAS ABNORMAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9354601 ↗
• MalfunctionJul 31, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PRESSURE GAUGE ABNORMALITY OCCURRED. A 26 ENCORE INFLATION DEVICE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, AN ABNORMALITY ON THE PRESSURED GAUGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8845650 ↗
• MalfunctionJul 19, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE GAUGE INACCURACY OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 26 ENCORE INFLATION DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, AS POSITIVE PRESSURE WAS APPLIED FROM 12ATM TO 14ATM, THE GAUGE NEEDLE SUDDENLY TURNED 360 DEGREES CLOCKWISE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807579 ↗
• MalfunctionJul 5, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE SEAL WAS COMPROMISED. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING PREPARATION, A CRACK WAS OBSERVED IN THE PLASTIC CASE CONTAINING THIS DEVICE. THE DEVICE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764528 ↗
• MalfunctionJun 12, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE ASEPTIC PACKAGING WAS DAMAGED. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE ASEPTIC PACKAGING OF THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8691418 ↗
• MalfunctionJun 11, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE ASEPTIC PACKAGING WAS DAMAGED. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE ASEPTIC PACKAGING OF THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8688772 ↗
• MalfunctionOct 8, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND ON THE DEVICE. AN ENCORE 26 INFLATION DEVICE WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT DIRT WAS FOUND ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MFR: DURING THE VISUAL INSPECTION THE ENCORE WAS FOUND WITH A WHITE STAIN ON THE SIDE OF THE DEVICE, THE STAIN WAS NOTED TO BE ON THE INSIDE OF THE CLEAR HOUSING AND ON THE OUTSIDE OF THE BARREL. THE STAIN DID NOT OBSTRUCT THE GRADUATION MARKS IN THE BARREL. NO OTHER ISSUES NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944097 ↗