EDGE SYSTEM 11996 (REF 11996-000090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00883873784938), received between Apr 8, 2021 and Jun 23, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (4 reports).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Patient Device Interaction Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE DEFIBRILLATION PADS ON THEIR DEVICE DID NOT ATTACH TO THE PATIENT. THIS ISSUE MAY PREVENT THE DEVICE FROM PROVIDING THERAPY IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596146 ↗
• MalfunctionFeb 19, 2026Device Sensing Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEY WERE UNABLE TO CONNECT THE DEFIBRILLATION ELECTRODES TO THEIR DEVICE WHEN ATTEMPTED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387582 ↗
• MalfunctionJan 5, 2026Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODE COULD NOT BE PLUGGED IN. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956188 ↗
• MalfunctionJun 24, 2025Inadequate Lubrication

  PATIENT WAS UNDERGOING VT [VENTRICULAR TACHYCARDIA] ABLATION, PT WAS DEFIBRILLATED AND THE PATIENT SUSTAINED A BURN. THE PADS WERE CHANGED AND NOTED THAT SIMILAR PADS HAD LESS GEL/ADHESIVE THAN OTHERS FROM DIFFERENT LOTS. STRYKER WAS CONTACTED.

  Patient problems: Burn(s); Tachycardia

  MAUDE report 22317858 ↗
• MalfunctionMar 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE PADS WOULD NOT STICK TO THE PATIENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507179 ↗
• InjuryMay 23, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  STRYKER RECEIVED A NOTIFICATION FROM THE FDA THAT A CUSTOMER'S DEFIBRILLATION PADS FAILED TO DELIVER DEFIBRILLATION AS EXPECTED AND HAD TO BE SWITCHED OUT. THIS ISSUE IS PATIENT RELATED; THE CUSTOMER INDICATED A LIFE THREATENING EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388812 ↗
• MalfunctionAug 28, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DELIVER DEFIBRILLATION. THIS ISSUE IS PATIENT-RELATED; HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631319 ↗
• MalfunctionFeb 15, 2023Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ELECTRODE DID NOT HOLD A CHARGE. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376817 ↗
• InjuryMay 27, 2022Sparking

  UPON COMPLETING A CARDIAC CARDIOVERSION STAFF NOTED SPARKS COMING FROM DEFIBRILLATOR PAD ON PATIENT'S CHEST. AFTER CARDIOVERSION COMPLETED UPON REMOVING PAD, PATIENT WAS LEFT WITH REDDENED BURNED AREA NEAR PAD PLACEMENT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Burn(s)

  MAUDE report 14547605 ↗
• MalfunctionApr 29, 2022Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEFIBRILLATION ELECTRODES WERE NOT CONNECTING TO THEIR DEVICE PROPERLY. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253964 ↗
• MalfunctionMar 23, 2022Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THEY RECEIVED PRODUCT WHERE THE PACKAGE WAS EMPTY AND DID NOT CONTAIN THE DEFIB ELECTRODE. THIS WAS NOTICED ON INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869210 ↗
• MalfunctionJan 26, 2022Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE PATIENT'S ECG RHYTHMS WERE NOT OBTAINABLE VIA THEIR DEFIBRILLATION ELECTRODES. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358568 ↗
• MalfunctionMay 7, 2021Failure to Sense; Failure to Sense

  A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR ELECTRODES DID NOT WORK WHEN CONNECTED TO THE PATIENT DURING USE. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788550 ↗
• MalfunctionApr 27, 2021Connection Problem; Connection Problem

  THE CUSTOM CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THEIR DEVICE ON A PATIENT AND THE DEFIBRILLATION ELECTRODES WERE NOT BEING PICKED UP BY THE DEVICE AND THE DEVICE GAVE A MESSAGE TO APPLY THEM. THE USERS CONFIRMED PROPER ELECTRODE CONNECTION AND POWER CYCLED THE DEVICE, BUT THE ISSUE WAS NOT RESOLVED. A 2ND SET OF ELECTRODES WAS OBTAINED AND USED, WHICH RESOLVED THE CONNECTION ISSUE. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732600 ↗
• MalfunctionApr 9, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THEIR DEVICE ON A PATIENT AND THE DEVICE WAS UNABLE TO DELIVER A SHOCK TO A PATIENT WITH A VENTRICULAR FIBRILLATION RHYTHM. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641490 ↗
• MalfunctionApr 8, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE ELECTRODE ACCESSORY FAILED TO PROVIDE DEFIBRILLATION. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. THE CUSTOMER INDICATED A BACK UP DEVICE WAS USED AND THE PATIENT SURVIVED AND IS NEUROLOGICALLY INTACT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 11634830 ↗