Heartstring III System 4.3MM HSK-3043Recalls & reported problems

Summary

The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 00607567700321), received between Jul 30, 2020 and Aug 20, 2026 — classified as 15 injuries, 250 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (129 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K130382); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 15, 2025Class IIOpen, Classified

   Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

   Z-2588-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 265 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50345155 ↗
• MalfunctionJul 27, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035225 ↗
• MalfunctionMar 18, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT THE HST III SYSTEM (3.8 MM) WAS LOADED NORMALLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), BUT THE SEAL BECAME CAUGHT ON THE TIP OF THE LOADER, PREVENTING SMOOTH REMOVAL AND ATTACHMENT. DEEMING THE PRODUCT TO BE A MECHANICAL DEFECT, IT WAS IMMEDIATELY REPLACED WITH A NEW ONE. RELOADING AND ATTACHMENT WERE SUBSEQUENTLY PERFORMED NORMALLY, ALLOWING THE SURGERY TO BE COMPLETED WITHOUT A HITCH.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625310 ↗
• MalfunctionMar 10, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT DURING LOADING THE SEAL, A SEAL REMAINED INSIDE THE LOADER, MAKING IT DIFFICULT TO USE. ANOTHER SEAL OF THE SAME PRODUCT WAS TAKEN OUT AND USED WITHOUT ANY PROBLEMS. NO HARM TO THE PATIENT'S HEALTH. NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556491 ↗
• MalfunctionMar 5, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT THE SEAL FROM THE HST III SYSTEM (4.3 MM) COULD NOT BE LOADED INTO THE DELIVERY DEVICE DURING THE LOADING PROCEDURE, RENDERING IT UNUSABLE FOR CLINICAL USE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE HEALTH EFFECTS TO THE PATIENT, NO ADDITIONAL PROCEDURES WERE REQUIRED, AND THERE WERE NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518968 ↗
• MalfunctionFeb 20, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT DURING PROCEDURE THE DELIVERY DEVICE OF THE HST III SYSTEM (3.8MM) WAS LOADED NORMALLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), BUT THE SEAL BECAME CAUGHT ON THE TIP OF THE LOADER, PREVENTING SMOOTH REMOVAL AND ATTACHMENT. THE SEAL GOT STUCK IN THE LOADING DEVICE PRIOR TO DEPLOYMENT IN THE AORTA. THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW ONE. THERE WAS A 7-10 MIN DELAY.

  Patient problems: Insufficient Information

  MAUDE report 24399285 ↗
• MalfunctionJan 29, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT IN STEP 4, THE SEAL REMAINED IN THE TUBE OF THE HST III SYSTEM (4.3MM). THE SEAL REMAINED IN THE LOADING DEVICE. THE SEAL COULD NOT BE REMOVED. THE NEW DEVICE WAS USED. THERE WAS NO DELAY AND IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207968 ↗
• MalfunctionJan 5, 2026Fitting Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969154 ↗
• MalfunctionDec 10, 2025Activation Problem; Activation Problem

  THE HOSPITAL REPORTED THAT THE HST III SYSTEM (4.3MM) DID NOT OPEN PROPERLY INSIDE THE BLOOD VESSEL, AND IT WAS DETERMINED THAT THE AMOUNT OF BLEEDING WAS GREATER THAN NORMAL, SO CONTINUED USE OF THE PRODUCT WAS ABANDONED. A NEW PRODUCT WAS ISSUED AND THIS TIME IT WAS ABLE TO BE USED WITHOUT ANY PROBLEMS. THERE WAS NO HARM TO THE PATIENT'S HEALTH, BUT THE CURRENT PRODUCT COULD NOT BE COLLECTED AS IT WAS DISPOSED OF BY THE HOSPITAL. THE AMOUNT OF BLOOD LOSS WAS NOT SIGNIFICANT ENOUGH TO REQUIRE ADDITIONAL TREATMENT SUCH AS A BLOOD TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767926 ↗
• MalfunctionNov 27, 2025Fitting Problem; Fitting Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (4.3MM) AFTER MAKING AN INCISION WITH A CUTTER, A SEAL WAS INSERTED, BUT IT WAS NOT POSITIONED PROPERLY. ANOTHER MANUFACTURER DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO RISK TO THE PATIENT'S HEALTH. NO ADDITIONAL TREATMENT NEEDED. A CENTRAL ANASTOMOSIS DEVICE (ENCLOSED) FROM ANOTHER COMPANY WAS USED AND HAS BEEN DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664687 ↗
• MalfunctionNov 27, 2025Activation Problem; Activation Problem

  N/A.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664370 ↗
• MalfunctionNov 12, 2025Fitting Problem; Fitting Problem

  THE HOSPITAL REPORTED THAT HST III SYSTEM (4.3MM) CRIMPED WHEN THE TECHNICIAN TRIED TO LOAD THE DEVICE. THE DEVICE CRIMPED WHILE LOADING SEAL, THE SEAL FAILED TO UNFOLD/UNWRAP, THIS WAS WHILE PREPPING DEVICE OUTSIDE OF BODY, THE SEAL REMAINED IN THE LOADING DEVICE. THE MALFUNCTION HAPPENED DURING PROCEDURE WHILE PREPPING DEVICE ON BACK TABLE. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE. NO HARM TO PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536111 ↗
• MalfunctionNov 7, 2025Activation Problem; Activation Problem

  RELATED TO (B)(4). THE HOSPITAL REPORTED THAT THE FIRST HST III SYSTEM DIDN'T DEPLOY AFTER THE SURGEON PREPPED IT FOR USE. THE SECOND HST III SYSTEM WAS REQUESTED BY THE SURGEON AND IT WAS PREPPED FOR USE AND FAILED AGAIN. THE THIRD HST III SYSTEM FINALLY DEPLOYED AS EXPECTED BY THE SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 23501380 ↗
• MalfunctionNov 7, 2025Activation Problem; Activation Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23501377 ↗
• MalfunctionSep 9, 2025Fitting Problem; Fitting Problem

  THE HOSPITAL REPORTED THAT THEY HAD A HST III SYSTEM (4.3 MM) MISFIRE. WHEN PULLING THE PLUNGER FROM THE LOADING DEVICE, THE SEAL DID NOT PROPERLY LOAD IN THE DELIVERY TUBE. OPENED A NEW KIT TO COMPLETE THE PROCEDURE. ONLY DELAY WAS LENGTH OF TIME TO OPEN A NEW KIT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008808 ↗
• MalfunctionAug 29, 2025Fitting Problem; Fitting Problem

  RELATED TO: (B)(4). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, FOUR HST III SYSTEM (4.3MM) DID NOT LOAD IN THE DELIVERY TUBE. THIS OCCURRED DURING THE SAME CASE AND INVOLVED THE SAME PATIENT. OPENED ANOTHER KIT TO COMPLETE THE PROCEDURE. THE ONLY DELAY WAS THE LENGTH OF TIME TO OPEN A NEW KIT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923659 ↗
• MalfunctionAug 29, 2025Fitting Problem; Fitting Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923649 ↗
• MalfunctionAug 29, 2025Fitting Problem; Fitting Problem

  RELATED TO: (B)(4). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, FOUR HST III SYSTEM (4.3MM) DID NOT LOAD IN THE DELIVERY TUBE. THIS OCCURRED DURING THE SAME CASE AND INVOLVED THE SAME PATIENT. OPENED ANOTHER KIT TO COMPLETE THE PROCEDURE. THE ONLY DELAY WAS THE LENGTH OF TIME TO OPEN A NEW KIT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923545 ↗
• MalfunctionAug 22, 2025Fitting Problem; Fitting Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877759 ↗
• MalfunctionAug 14, 2025Fitting Problem; Fitting Problem

  THE HOSPITAL REPORTED THAT DURING PROCEDURE, HST III SYSTEM (4.3MM) WASN¿T LOADED CORRECTLY, CASE WAS COMPLETED WITH ANOTHER HST. NO DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806515 ↗
• MalfunctionAug 4, 2025Fitting Problem; Fitting Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698525 ↗
• MalfunctionJul 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HOSPITAL REPORTED THAT WHEN USING HST III SYSTEM (4.3MM) THE SEALING DEVICE WAS NOT SET AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING A SUBSTITUTE PRODUCT. THERE WAS NO DELAY IN THE PROCEDURE AND NO HEALTH HAZARD TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646393 ↗
• MalfunctionJul 28, 2025Fitting Problem; Fitting Problem

  RELATED TO: (B)(4). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HS III PROXIMAL SEAL SYTEM (4.3MM) FAIL TO LOAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637739 ↗
• InjuryJul 28, 2025Activation Problem; Activation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 22634210 ↗
• MalfunctionJul 28, 2025Fitting Problem; Fitting Problem

  RELATED TO : TW (B)(4), TW (B)(4). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HS III PROXIMAL SEAL SYTEM (4.3MM) FAIL TO LOAD AS THEY WERE LOADING THEM FOR USE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130382. One submission often covers many models, so check the product and lot details in each record.

• Z-2587-2025 · Aug 15, 2025 · Open, Classified
  Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
• Z-2586-2025 · Aug 15, 2025 · Open, Classified
  Heartstring III Proximal Seal System. Intravascular anastomosis occluder.