Encore 26 M0067101140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729755814), received between May 18, 2017 and Sep 14, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 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 8 most recent of 8 reports, 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 ↗
• MalfunctionNov 17, 2020Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO AN ENCORE INFLATION DEVICE AND A NEPHROMAX DILATATION BALLOON CATHETER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE AND A NEPHROMAX DILATATION BALLOON CATHETER WERE USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED TO 16 PSI. SUBSEQUENTLY, THE INFLATION MEDIUM OF THE BALLOON WAS FOUND FILLING THE RETROPERITONEUM OF THE PATIENT WHICH MADE THE IMAGE OF THE KIDNEY UNDER FLUOROSCOPY TOO CHALLENGING TO SEE. REPORTEDLY, THERE ARE TWO WIRES IN THE KIDNEY AT THAT TIME. THE ENCORE INFLATION DEVICE WAS NOTED HARD TO USE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, AND THE PATIENT HAD TO BE BROUGHT BACK TO THE HOSPITAL AT A LATER DATE FOR ANOTHER PROCEDURE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10850696 ↗
• MalfunctionOct 5, 2020Material Rupture

  PERCUTANEOUS NEPHROLITHOTOMY ATTEMPTED. UPON INFLATING NEPHROSTOMY BALLOON CATHETER FILLED WITH CONTRAST, BALLOON RUPTURED WHILE IN THE PATIENT. THIS CAUSED CONTRAST TO SPILL WHICH PREVENTED CONTINUING WITH THE CASE DUE TO POOR VISUALIZATION. CASE ABORTED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10626432 ↗
• MalfunctionApr 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS UNPACKED FOR AN ANGIOPLASTY PROCEDURE FOR THE HEART ARTERY PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THERE WERE SOME LIQUID INSIDE THE TUBING. REPORTEDLY, THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957133 ↗
• MalfunctionJun 5, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION DEVICE WAS UNPACKED FOR A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY NOTICED THAT THE DEVICE'S INNER TRAY WAS CRACKED. THEY OPENED ANOTHER ENCORE 26 INFLATION DEVICE TO COMPLETE THE PROCEDURE. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6613173 ↗
• MalfunctionMay 18, 2017Incorrect Measurement; Incorrect Measurement

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-01612 PERTAINS TO THE FIRST ENCORE INFLATION DEVICE AND MANUFACTURER REPORT # 3005099803-2017-01613 PERTAINS TO THE SECOND ENCORE INFLATION DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ENCORE INFLATION DEVICES WERE USED IN THE SUPERIOR FEMORAL ARTERY DURING AN ANGIOGRAM OF THE LEG PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GAUGE OF THE DEVICE WOULD NOT SHOW ANY PRESSURE AND THE GAUGE NEEDLE DID NOT MOVE AT ALL. IT WAS ALSO NOTICED THAT THE THREADED PLUNGER WOULD NOT LOCK AND SEEMED TO BE LOOSE. THE SAME EVENT OCCURRED WITH THE SECOND INFLATION DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6577534 ↗
• MalfunctionMay 18, 2017Incorrect Measurement; Incorrect Measurement

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-01612 PERTAINS TO THE FIRST ENCORE INFLATION DEVICE AND MANUFACTURER REPORT # 3005099803-2017-01613 PERTAINS TO THE SECOND ENCORE INFLATION DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ENCORE INFLATION DEVICES WERE USED IN THE SUPERIOR FEMORAL ARTERY DURING AN ANGIOGRAM OF THE LEG PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GAUGE OF THE DEVICE WOULD NOT SHOW ANY PRESSURE AND THE GAUGE NEEDLE DID NOT MOVE AT ALL. IT WAS ALSO NOTICED THAT THE THREADED PLUNGER WOULD NOT LOCK AND SEEMED TO BE LOOSE. THE SAME EVENT OCCURRED WITH THE SECOND INFLATION DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6577516 ↗
• MalfunctionMay 18, 2017Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE INFLATION DEVICE WAS USED IN THE SUPERIOR FEMORAL ARTERY DURING AN ANGIOGRAM OF THE LEG PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GAUGE OF THE DEVICE WOULD NOT SHOW ANY PRESSURE AND THE GAUGE NEEDLE DID NOT MOVE AT ALL. IT WAS ALSO NOTICED THAT THE THREADED PLUNGER WOULD NOT LOCK AND SEEMED TO BE LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6577508 ↗