remede System Implantable Pulse Generator 1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00857688007001), received between Jan 9, 2026 and Feb 4, 2026 — classified as 7 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  ON 9/8/2023 WE WERE NOTIFIED THAT THIS PATIENT WAS BEING SCHEDULED FOR AN URGENT FULL DEVICE EXTRACTION ON (B)(6) 2023 DUE TO A POCKET INFECTION. THE PATIENT REPORTED SOMETIME IN (B)(6) FEELING SOME RUBBING ON THE DEVICE FROM SEATBELT USE THAT EVENTUALLY LEAD TO THE DEVELOPMENT OF A RED AREA AROUND THE SUPERIOR-LATERAL CORNER OF THE DEVICE. HE DID NOT REPORT THE ISSUE TO HIS MEDICAL PROVIDERS FOR MULTIPLE WEEKS. BY THAT TIME IT WAS CLEAR THAT A POCKET INFECTION HAD DEVELOPED. A 3M WOUND VAC WAS PLACED AT THE END OF THE PROCEDURE. A 3M WOUND VAC WAS PLACED AT THE END OF THE PROCEDURE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24261846 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  THE REMEDE DEVICE WAS EXPLANTED DUE TO INFECTION ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24203179 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  RECEIVED DEVICE IMPLANTED ON (B)(6) 2021. PATIENT WAS EVALUATED BY DR. (B)(6) ON (B)(6)2024 FOR COMPLAINTS OF POCKET PAIN ON (B)(6) 2024 AT THE REMEDE DEVICE IMPLANT SITE. PHYSICIAN NOTED THAT HE WAS CONCERNED ABOUT A PENDING POCKET EROSION. ON (B)(6) 2024, THE PATIENT UNDERWENT A POCKET REVISION WITH REMOVAL OF THE ORIGINAL IPG (1001-2165) AND PLACEMENT OF A NEW IPG SUBMUSCULAR.

  Patient problems: Pocket Erosion

  MAUDE report 24203085 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 PATIENT HAD LEAD REVISION WITH A NEW LEAD IMPLANTED. ON (B)(6) 2023 THE PATIIENT HAD A WOUND CHECK WHICH NOTED THE INCISION HAD YELLOWISH DRAINAGE. ORAL KELFEX WAS PRESCRIBED. PATIENT STATED TO THE NP AT THAT TIME THAT HE DID NOT TAKE THE ANTIBITOCS PRESCRIVED BY DR (B)(6) AFTER HIS REVISON. ON (B)(6) 2023 PATEINT WAS HOSPITALIZED FOR AN INFECTED DEVICE. ON (B)(6) 2023 PATIENT UNDERWENT A POCKET REVISON FOR INFECTION WHICH WAS DESCRIBED AS "THE DEVICE WAS RELEASED FROM THE POCKET BUT REMAINED CONNECTED TO THE LEADS. THE DEVICE AND THE LEADS WERE WIPED SORELY AND THE POCKET WAS IRRIGATED PROFUSELY AFTER OBTAINING CULTURES. THE POCKET WAS EXTENDED MEDIALLY. THE DEVICE WAS PLACED BACK IN THE POCKET AND WAS SECURED TO THE UNDERLYING TISSUE USING SINGLE 2.0 SILK SUTURE. AN ABSORBABLE ANTIBIOTIC ENVELOPE WAS PLACED IN THE POCKET SUBCUTANEOUSLY SUPERFICIAL DEVICE. THE INCISON WAS CLOSED USING INTERRUPTED 3.0 NYLON SUTURES. A DRESSING WERE THEN APPLIED." ON (B)(6) 2024 THE PATIENT HAD A FOLLOW UP WOUND CHECK THAT THE WOUND "LOOKED GOOD WITH NO SIGNS OF INFECTION" PER THE PHYSICIAN OFFICE. (B)(6) 2024: PATIENT HAD ANOTHER PHYSICIAN VISIT WITH DR. (B)(6) WHO INDICATED THE SITE

  Patient problems: Post Operative Wound Infection

  MAUDE report 24164481 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THE PATIENT HAD A POCKET REVISION DUE TO DISCOMFORT FROM DEVICE NEAR CALVICLE. ON (B)(6) 2024 ZOLL RESPICARDIA PERSONNEL WERE NOTIFIED BY THE PATIENT THAT HE WAS EXPERIENCING ISSUES AT THE POCKET SITE OF HIS REMEDE SYSTEM WHICH WAS DESCRIBED AS "THINNING OF TISSUE AT IMPLANT SITE". PATIENT WAS EVALUATED BY DR. (B)(6) ON (B)(6) 2024. PATIENT WAS EVALUATED BY DR. (B)(6) ON UNKNOWN DATE AND NOTED AT THAT TIME TO HAVE EROSION OF THE LEAD THROUGH THE SKIN. ON (B)(6) 2024 THE SYSTEM WAS EXPLANTED WITHOUT ISSUE. AT THE TIME OF THE EXPLANT, DR. (B)(6) VISUALIZED THE POCKET AND NOTED THAT DURING THE INITIAL POCKET REVISION ON (B)(6) 2022, THE DEVICE WAS MOVED TO A SUB PECTORAL POCKET BUT THE LEAD HAD NOT BEEN TUNNELED TO THAT SUBPEC POCKET AND IT WAS HIS OPINION THAT WAS THE REASON FOR THE EROSION CAUSING. THE SYSTEM TO BE REMOVED ON (B)(6) 2024.

  Patient problems: Pocket Erosion

  MAUDE report 24096364 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT COMPLAINED OF WEIGHT LOSS WHICH IN TURN CAUSED HER REMEDE SYSTEM DEVICE TO MOVE AND BECOME UNCOMFORTABLE WITHIN THE GENERATOR POCKET. ON (B)(6) 2024, THE PATIENT WAS EVALUATED BY PHYSICIAN WHO NOTED A SIGNIFICANT RECENT WEIGHT LOSS WITH SMALL AREA AT THE LATERAL ASPECT OF POCKET WITH DISCOLORATION AND ERYTHEMA CONCERNING FOR A POTENTIAL LOCALIZED SKIN INFECTION. PATIENT WAS PUT ON 10 DAY ORAL ANTIBIOTIC REGIMEN. ON (B)(6) 2024, THE PATIENT WAS EVALUATED BY PHYSICIAN WITH NO OVERT SIGN OF INFECTION ON (B)(6) 2024, THE PATIENT WAS EVALUATED BY PHYSICIAN AND THE DISCOLORATION APPEARED SLIGHTLY IMPROVED. NO ERYTHEMA. ON (B)(6) 2024, THE PATIENT CONTACTED THE PHYSICIAN INDICATED THE DEVICE SITE WAS "OOZING YELLOW FLUID". THE PHYSICIAN REVIEWED THE DEVICE SITE STATING THE DEVICE HAD ERODED AND THE POCKET IS NOW INFECTED. PHYSICIAN RECOMMENDED EXPLANT OF REMEDE SYSTEM. ON (B)(6) 2024, THE PATIENT HAD THE REMEDE SYSTEM EXPLANTED. THE PATIENT WAS TREATED WITH A WOUND VAC AND IV ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24085349 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 THE PATIENT WAS IMPLANTED WITH A REMEDE SYSTEM FOR CENTRAL SLEEP APNEA. THE PATIENT WAS RECEIVING THERAPY AND DOING WELL WITH CSA CONTROL NOTED ON PSG. ON (B)(6) 2024 THE PATIENT HAD AN OFFICE VISIT AFTER MISSING MULTIPLE SCHEDULED VISITS. PATIENT WAS AGITATED AND STATING THE THERAPY WAS NOT BENEFITING HER AND THAT SHE WANTED THE DEVICE EXPLANTED. IT WAS NOTED AT THAT TIME BY THE HUSBAND AND PHYSICIAN THAT THE PATIENT HAD INCREASED COGNITIVE IMPAIRMENT WITH POSSIBLE ONSET OF DEMENTIA WITH A CONSULTATION TO NEUROLOGY. ON (B)(6) 2024 THE PATIENT HAD AN APPOINTMENT WITH SLEEP PHYSICIAN AND PATIENT WAS EDUCATED ON SLEEP HYGIENE AND IMPORTANCE OF ESTABLISHING A NIGHTLY ROUTINE. PATIENT INDICATED SHE DID NOT WANT TO MAKE ANY CHANGES TO HER ROUTINE AND THAT SHE WANTED THE DEVICE EXPLANTED. THE PHYSICIAN AND PATIENT DISCUSSED AND DEVICE WAS PLACED IN "OFF" MODE. ON (B)(6) 2025 THE PATIENT CALLED THE PATIENT EDUCATION LINE AT ZOLL RESPICARDIA AND INDICATED ON AN UNKNOWN DATE SHE HAD HER IPG EXPLANTED AND ON (B)(6) 2024 SHE HAD A PROCEDURE TO HAVE THE REMEDE SYSTEM LEAD EXPLANTED. THE PATIENT INDICATED THAT WHEN THE PHYSICIAN, DR. (B)(6), ATTEMPTED TO REMOVE THE LEAD IT CAUSED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24022488 ↗