SMART 70145928Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925020801), received between Sep 13, 2019 and Oct 1, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K003214); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE PATIENT RECEIVED A SMART PISTON IMPLANT WHICH CRIMPED BOTH DURING AND POST PROCEDURE RESULTING IN ANOTHER PROCEDURE AT ANOTHER DATE. ACCORDING TO THE REPORT, THE PROBLEM FOUND WHEN THE USER USED IT FOR A PATIENT WHO HAD UNDERGONE STAPEDECTOMY ON (B)(6) 2022. ACCORDING TO THE REPORT, DURING THE PROCEDURE, CUSTOMER HAD TO OPEN A SECOND IMPLANT AS THE FIRST ONE CRIMPED BACK. HOWEVER, LATER ON, THIS PATIENT CAME IN FOR A REVISION STAPEDEDTOMY ON (B)(6) 2022 AND SAME ISSUE WAS OBSERVED. THE CUSTOMER REPLACED THE IMPLANT WITH BIG EASY (THIRD PARTY DEVICE) ACCORDING TO THE REPORT, PATIENT HAD THE STAPEDECTOMY ON THE OTHER SIDE ON (B)(6) 2022 AND A BIG EASY PISTON WAS USED FOR THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED . NO INJURY OR HARM WAS REPORTED. THIS EVENT INCLUDES TWO REPORTS . REPORT WITH PATIENT IDENTIFIER (B)(6) SMART PISTON MODEL 70145928 LOT SM960548 - CRIMPED SMART PISTON (DURING PROCEDURE AND WAS REPLACED WITH SECOND SMART PISTON). REPORT WITH PATIENT IDENTIFIER (B)(6) SMART PISTON MODEL 70145928 LOT PR966762.- CRIMPED SMART PISTON (FULLY IMPLANTED). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) SMART PISTON MODEL 70145928 LOT SM960548

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524806 ↗
• MalfunctionOct 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE PATIENT RECEIVED A SMART PISTON IMPLANT WHICH CRIMPED BOTH DURING AND POST PROCEDURE RESULTING IN ANOTHER PROCEDURE AT ANOTHER DATE. ACCORDING TO THE REPORT, THE PROBLEM FOUND WHEN THE USER USED IT FOR A PATIENT WHO HAD UNDERGONE STAPEDECTOMY ON (B)(6) 2022. ACCORDING TO THE REPORT, DURING THE PROCEDURE, CUSTOMER HAD TO OPEN A SECOND IMPLANT AS THE FIRST ONE CRIMPED BACK. HOWEVER, LATER ON, THIS PATIENT CAME IN FOR A REVISION STAPEDEDTOMY ON (B)(6) 2022 AND SAME ISSUE WAS OBSERVED. THE CUSTOMER REPLACED THE IMPLANT WITH BIG EASY (THIRD PARTY DEVICE). ACCORDING TO THE REPORT, PATIENT HAD THE STAPEDECTOMY ON THE OTHER SIDE ON (B)(6) 2022 AND A BIG EASY PISTON WAS USED FOR THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. NO INJURY OR HARM WAS REPORTED. THIS EVENT INCLUDES TWO REPORTS . REPORT WITH PATIENT IDENTIFIER (B)(6) SMART PISTON MODEL 70145928 LOT SM960548 - CRIMPED SMART PISTON (DURING PROCEDURE AND WAS REPLACED WITH SECOND SMART PISTON). REPORT WITH PATIENT IDENTIFIER (B)(6) SMART PISTON MODEL 70145928 LOT PR966762. CRIMPED SMART PISTON (FULLY IMPLANTED). OBSERVED ON (B)(6) 2022 DURING THE REVISION PROCEDURE. REPORT WITH PATIENT IDENTIFIER (B)(6) SMART

  Patient problems: Partial Hearing Loss

  MAUDE report 15522963 ↗
• MalfunctionSep 13, 2019Failure to Fire; Failure to Fire

  THE USER FACILITY REPORTED THAT WHILE A PHYSICIAN PERFORMED A STAPEDECTOMY, THE SMART PISTON DID NOT CRIMP AFTER TWO TIMES OF HEATING. THE USER CHANGED TO ANOTHER NEW SMART PISTON. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. A SMART PISTON AND THERMAL HANDLE WAS ALSO USED WITH THIS DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW SMART THERMAL TIP DEVICE. THE PROCEDURE WAS PROLONGED BY ABOUT 30 MINUTES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9038946 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003214. One submission often covers many models, so check the product and lot details in each record.

• Z-2813-2020 · Jul 14, 2020 · Terminated
  Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
• Z-2814-2020 · Jul 14, 2020 · Terminated
  Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662