Stable Base W-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10861779000274), received between Jan 17, 2017 and Apr 5, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MARCH 09TH, 2023, WE HAVE BEEN INFORMED AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL: SBW601) HAD BEEN USED. THE INITIAL REPORT STATED "I AM TRYING TO FIND OUT MORE INFORMATION ABOUT THE ELECTRODES I WAS SUPPLIED WITH FOR A 30 DAY CARDIAC MONITOR. I HAVE ATTACHED A PICTURE WITH PRODUCT INFORMATION. DO THESE ELECTRODES CONTAIN ANY LATEX? I HAD AN ALLERGIC REACTION AND I WOULD LIKE TO IDENTIFY IF IT IS LATEX (KNOWN ALLERGEN), ADHESIVE, OR SOMETHING ELSE. THE COMPANY WHO PROVIDED ME WITH THE ELECTRODES COULD NOT ANSWER MY QUESTION." ATTACHED TO THESE INITIAL REPORT A PHOTO WAS PROVIDED SHOWING A POUCH OF STABLE BASE ECG ELECTRODE LOT NUMBER: 220715-0153. ON MARCH 13RD, 2023 WE HAVE RECEIVED ADDITIONAL INFORMATION IN A FILLED IN QUESTIONAIRE. A MONITORING OF ARRHYTHMIA WAS PERFORMED. THE PATIENT SKIN WAS DESCRIBED AS NORMAL AND THE GENERAL STATE ALSO AS NORMAL. THE MEDICAL HISTORY WAS DESCRIBED AS "PSORIASIS, ECZEMA, MULTIPLE ALLERGIES INCLUDING LATEX, ASTHAMA". 5 ECG ELECTRODE PER USE HAVE BEEN PLACED IN THE CHEST / ABDOMEN AREA. IN TOTAL THE PATIENT USED 35 ELECTRODES IN 23 DAYS. THE PATIENT DESCRIBED THAT THE PROCEDURE SHOULD LAST FOR 30 DAYS BUT WAS "SHORTEN

  Patient problems: Itching Sensation; Rash

  MAUDE report 16680267 ↗
• InjuryMar 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, WE HAVE BEEN INFORMED ABOUT 26 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH BODYGUARDIAN MINI+ AND BODYGUARDIAN ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 26 REPORTS COVERING A PERIOD FROM DECEMBER 01ST - 28TH. NO MEDICAL INTERVENTION WAS NECESSARY FOR 25 INCIDENTS. FOR 1 INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. THE REPORTABLE EVENT DISCLOSED THAT THE PATIENT'S SKIN WAS PREPERED USING SOAP AND WATER BEFORE APPLYING THE ECG ELECTRODES. THE PATIENT EXPERIENCED "REDNESS, BLISTERS, BLEEDING". THE ECG ELECTRODES HAVE BEEN REMOVED "WHILE BATHING". IT WAS ALSO REPORTED THAT THE PATIENT HAS WORN ECG ELECTRODES FOR 2 DAYS AND HAD CHANGED THEM ONE TIME. NO SKIN IRRITITATION WAS VISIBLE BEFORE APPLYING THE ECG ELECTRODES. IT WAS STATED THAT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY AND THAT AN OINTMENT WAS PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blister

  MAUDE report 16500816 ↗
• InjuryMar 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, WE HAVE BEEN INFORMED ABOUT 32 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBT601 AND SBW601) HAD BEEN USED WITH BODYGUARDIAN ONE AND BODYGUARDIAN VERITE ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 32 REPORTS COVERING A PERIOD FROM (B)(6) 2020. NO MEDICAL INTERVENTION WAS NECESSARY FOR 29 INCIDENTS. FOR 3 INCIDENTS A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY BUT NO FURTHER DETAILS WERE GIVEN. BEFORE APPLYING THE ECG ELECTRODES, THE SKIN OF THE PATIENTS REQUIRING INTERVENTION WAS PREPARED USING WATER AND SOAP. THE 3 PATIENTS DEVELOPED ITCHING, BURNING SENSATION ON SKIN, BURNT SKIN, REDNESS, WELT, PEELING SKIN AND BLEEDING. ONE PATIENT REPORT PROVIDED THE INFORMATION THAT THE PATIENT PAUSED THE STUDY TO WAIT FOR THE SKIN IRRITATION TO HEAL. A MEDICAL INTERVENTION WAS NECESSARY. ALL OTHER 29 PATIENTS WERE PREPARED WITH DIFFERENT METHODS USING WATER AND SOAP, ALCOHOL, ALCOHOL WIPES OR SALINE WIPES BEFORE APPLYING THE ECG ELECTRODES. THE PATIENTS WERE EXPERIENCING "REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION ON SKIN, PEELING SKIN, BURNT SKIN, BLEEDING, OPEN SORES." N

  Patient problems: Blister; Burn(s); Burning Sensation; Itching Sensation; Rash; Skin Inflammation/ Irritation

  MAUDE report 11479879 ↗
• InjuryNov 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020, WE HAVE BEEN INFORMED ABOUT 10 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBT601 AND SBW601) HAD BEEN USED WITH BODYGUARDIAN ONE AND BODYGUARDIAN VERITE ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 10 REPORTS COVERING A PERIOD FROM (B)(6). ALL PATIENTS WERE PREPARED WITH DIFFERENT METHODS USING WATER AND SOAP, ALCOHOL, ALCOHOL WIPES OR SALINE WIPES BEFORE APPLYING THE ECG ELECTRODES. THE PATIENTS WERE EXPERIENCING THE "REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION ON SKIN, PEELING SKIN, BURNT SKIN, BLEEDING, OPEN SORES." NO MEDICAL INTERVENTION WAS NECESSARY FOR ANY OF THESE 10 INCIDENTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burning Sensation; Irritation; Itching Sensation; Rash

  MAUDE report 10903606 ↗
• InjuryNov 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OCTOBER 19TH, 2020, WE HAVE BEEN INFORMED ABOUT 14 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBT601) HAD BEEN USED WITH BODYGUARDIAN ONE AND BODYGUARDIAN VERITE ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 14 REPORTS COVERING A PERIOD FROM (B)(6). NO MEDICAL INTERVENTION WAS NECESSARY FOR 13 INCIDENTS. FOR 1 INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY BUT NO FURTHER DETAILS WERE GIVEN. BEFORE APPLYING THE ECG ELECTRODES, THE SKIN OF THE PATIENT REQUIRING INTERVENTION WAS PREPARED USING WATER AND SOAP. HE DEVELOPED OPEN SORES AND BLEEDING. THE PATIENT PAUSED THE STUDY TO WAIT FOR THE SKIN TO HEAL. A MEDICAL INTERVENTION WAS NECESSARY. ALL OTHER PATIENTS WERE PREPARED WITH DIFFERENT METHODS USING WATER AND SOAP, ALCOHOL, ALCOHOL WIPES OR SALINE WIPES BEFORE APPLYING THE ECG ELECTRODES. THE PATIENTS WERE EXPERIENCING THE "REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION ON SKIN, PEELING SKIN, BURNT SKIN, BLEEDING, OPEN SORES." NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burning Sensation; Irritation; Itching Sensation; Rash

  MAUDE report 10850224 ↗
• InjuryNov 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OCTOBER 19TH, 2020, WE HAVE BEEN INFORMED ABOUT 11 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601) HAD BEEN USED WITH BODYGUARDIAN ONE AND BODYGUARDIAN VERITE ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 11 REPORTS COVERING A PERIOD FROM (B)(6). NO MEDICAL INTERVENTION WAS NECESSARY FOR 8 INCIDENTS. FOR 3 INCIDENTS A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY BUT NO DETAILS WERE GIVEN. BEFORE APPLYING THE ECG ELECTRODES, IN TWO CASES THE SKIN OF THE PATIENTS REQUIRING INTERVENTION WERE PREPARED USING WATER AND SOAP. THE DEVELOPED REDNESS, ITCHING, PEELING SKIN, RASH, BLISTERS, BURNING SENSATION, OPEN SORES. MEDICAL INTERVENTIONS WERE NECESSARY. THE THIRD PATIENT'S SKIN WAS NOT PREPPED. THE ELECTRODES STAYED ON A TOTAL OF 11 DAYS AND WERE CHANGED ONCE WITHIN THIS PERIOD. HE DEVELOPED REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION, PEELING SKIN, BURNT SKIN, BLEEDING SKIN, OPEN SORES. THE PATIENT PAUSED THE STUDY TO WAIT FOR THE SKIN IRRITATION TO HEAL. A MEDICAL INTERVENTION WAS NECESSARY. ALL OTHER PATIENTS WERE PREPARED WITH DIFFERENT METHODS USING WATER AND SOAP, ALCOHOL, AL

  Patient problems: Burning Sensation; Irritation; Itching Sensation; Rash

  MAUDE report 10850219 ↗
• InjuryAug 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020, WE HAVE BEEN INFORMED ABOUT 9 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH BODYGUARDIAN MINI+ AND BODYGUARDIAN ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 9 REPORTS COVERING A PERIOD FROM (B)(6). NO MEDICAL INTERVENTION WAS NECESSARY FOR 8 INCIDENTS. FOR 1 INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. THE REPORTABLE EVENT DISCLOSED THAT THE PATIENT'S SKIN WAS PREPERED USING WATER AND SOAP BEFORE APPLYING THE ECG ELECTRODES. THE PATIENT EXPERIENCED THE "REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION ON SKIN, PEELING SKIN, BURNT SKIN, BLEEDING, OPEN SORES." IT WAS ALSO REPORTED THAT THE PATIENT STOPPED THE STUDY AFTER 5 DAYS. IT WAS STATED THAT A MEDICAL INTERVENTION WAS NEEDED TREAT THE INJURY BUT NO DETAILS WERE GIVEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Burning Sensation; Irritation; Itching Sensation; Rash

  MAUDE report 10395106 ↗
• InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JULY 15TH, 2019, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH A VERITY ECG MONITOR. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 53 ACCOUNTS FROM (B)(6) 2019 TO (B)(6) 2019." THE REPORT REFERRED TO 53 SEPARATE CASES, INVOLVING A TOTAL OF 7 DIFFERENT LOT/BATCHES OF MODEL SBT601 AND 14 DIFFERENT LOT/BATCHES OF MODEL SBW601 . NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.

  Patient problems: Irritation

  MAUDE report 8845443 ↗
• InjuryDec 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601) AND AN UNKNOWN HEART MONITORING RECORDER HAD BEEN USED. THE INITIAL REPORT "(B)(6) 2018 INCOMING PATIENT STATED THAT THEY ARE MAILING THE DEVICE BACK RIGHT NOW DUE TO THE ELECTRODES- THEY HAVEN'T USED THE MONITOR THE LAST TWO DAYS THEIR SKIN WAS OOZING AND HAD OPENED SORES. THEY ONLY HAD THE MONITOR ON FOR ONLY 2 TO 3 DAYS AND WHEN THEY TOOK THE ELECTRODES OFF IT RIPPED THEIR SKIN (...)." NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURY HAD TO BEEN TREATED AS THE REPORTER STATED IT WAS ALL THE INFORMATION HE COULD PROVIDE.

  Patient problems: Tissue Damage

  MAUDE report 8154235 ↗
• InjuryJan 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND MODEL SBT601) AND A VERITÉ-CEM MACHINE AND IMD POST EVENT MACHINE HAD BEEN USED IN A HEART MONITORING PROCEDURE WITH A DURATION OF 30 DAYS. THE PATIENT'S SKIN TYPE WAS DESCRIBED AS NORMAL, NO HAIR AND THE BODY TYPE AS "ATHLETIC - DARK SKIN TONE". THE SKIN WAS CLEANED WITH "SOAP AND WATER", NOT SHAVEN, NOT DISINFECTED, AND DRIED. IT WAS REPORTED THAT THE PATIENT DEVELOPED A SKIN REACTION ON (B)(6) 2016 WITHIN THE FIRST 24 HOURS OF USE ("RED & BUMPY - ITCHING & BURNING"). THE PATIENT REPORTED THAT THE SKIN REACTION WAS EXACTLY UNDER THE ELECTRODES. THE SKIN REACTION WAS LOCATED ABOVE AND BELOW BREAST AREA ON THE LEFT AND RIGHT SIDE. TWO DIFFERENT DOCTORS WERE CONSULTED, "ONE GAVE CREAM FOR 15 DAYS AND THE OTHER GAVE THE SAME IN LOTION FORM FOR 30 DAYS. - THE CREAM/LOTION WAS AUGMENTED BETAMETHASONE DIPRIONATE 0.05". IT APPEARS THE PATIENT CONTINUED THE MONITORING STUDY FOR THE ENTIRE 30 DAYS DESPITE OF THE SKIN REACTIONS AND HAD THESE REACTIONS TREATED IN PARALLEL. IT WAS ALSO STATED THAT THE REACTION JUST STARTED FADING THE WEEK OF (B)(6) 2016.

  Patient problems: Skin Irritation

  MAUDE report 6255574 ↗