Heartstring III System 3.8MM HSK-3038Recalls & reported problems

Summary

The FDA's MAUDE database contains 809 adverse event reports that list this exact device (DI 00607567700314), received between Jul 2, 2020 and Sep 28, 2026 — classified as 4 deaths, 51 injuries, 754 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (432 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-2587-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 809 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914460 ↗
• MalfunctionSep 23, 2026Fitting Problem

  The hospital reported that during a coronary artery bypass procedure, HST III System (3.8MM) could not be inserted correctly. When the HST III System (3.8MM) was pulled out, the entire system became stuck. Another one was opened, and the same defect occurred. Both Heartstring devices were used on the same patient. In both cases, after steps 1 through 3 proceeded without incident, step 4, the removal of the charged device, occurred. At this point, everything remained in the charging system, and I was left holding only the empty casing. procedure could be performed with an alternative device (EnClose). There was no major delay for the patient, however, we then had to clamp the ascending aorta tangentially. No harm to the patient; Can be completed without further problems. Based on the provided photo the seal is still in the loading device.Related to (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868738 ↗
• MalfunctionSep 23, 2026Fitting Problem

  The hospital reported that the seal did not properly load into the loading device in HST III System (3.8MM). It was determined that it could not be used safely. A new device was brought out, and this time it loaded successfully and was used. No injury was reported. There was no delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866335 ↗
• MalfunctionSep 22, 2026Fitting Problem

  The hospital reported that during a coronary artery bypass procedure, HST III System (3.8MM) could not be inserted correctly. When the HST III System (3.8MM) was pulled out, the entire system became stuck. The seal remained in the charging device . The seal did not make contact with the patient¿s aorta. Another one was opened, and the same defect occurred. Both Heartstring devices were used on the same patient. In both cases, after steps 1 through 3 proceeded without incident, step 4, the removal of the charged device, occurred. At this point, everything remained in the charging system, and I was left holding only the empty casing. procedure could be performed with an alternative device (EnClose). There was no major delay for the patient, however, we then had to clamp the ascending aorta tangentially. No harm to the patient; Can be completed without further problems. Based on the provided photo the seal is still in the loading device.Related to (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852349 ↗
• MalfunctionSep 18, 2026Fitting Problem; Detachment of Device or Device Component

  The hospital reported that there was an attempted to load a HST III System (3.8MM) into a delivery device using the IFU method during an OPCAB surgery. However, the seal became stuck on the loader, preventing normal loading, and the delivery device handle detached. Determined to be a product defect, a new product was used, and the surgery was successfully completed. The patient's condition is stable. Based on the photo provided by the complainant, the seal got stuck inside delivery device. There was a procedural delay of approximately 7 minutes.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815062 ↗
• MalfunctionSep 17, 2026Fitting Problem; Detachment of Device or Device Component

  The hospital reported that there was an attempt to load a HST III System (3.8MM) into a delivery device using the IFU method. However, the seal became stuck on the loader, preventing normal loading, and the delivery device handle detached. Determined to be a product defect, a new product was used, and the surgery was successfully completed. The patient's condition is stable. There was a procedural delay of approximately 7¿8 minutes.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801463 ↗
• MalfunctionSep 15, 2026Failure to Unfold or Unwrap

  The hospital reported that after loading the HST III System (3.8MM), the umbrella part did not open properly when released for use. The tension spring was not adjusted and the seal was not attached because it was not properly inserted into the aorta. New device was used to complete the procedure. No delay, no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774011 ↗
• MalfunctionSep 15, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774010 ↗
• MalfunctionSep 14, 2026Unraveled Material; Insufficient Device Problem Information

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

  MAUDE report 50763995 ↗
• MalfunctionAug 26, 2026Fitting Problem

  n/a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451484 ↗
• MalfunctionAug 17, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274052 ↗
• MalfunctionAug 17, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274049 ↗
• MalfunctionAug 14, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50250813 ↗
• MalfunctionAug 6, 2026Fitting Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50151644 ↗
• MalfunctionAug 5, 2026Fitting Problem; Detachment of Device or Device Component

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137927 ↗
• MalfunctionJul 31, 2026Fitting Problem

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

  MAUDE report 50096039 ↗
• MalfunctionJul 29, 2026Fitting Problem

  N/A

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

  MAUDE report 50069044 ↗
• MalfunctionMay 18, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT IN STEP NUMBER 4, THE GASKET REMAINED INSIDE THE CYLINDER. THE SEAL REMAINED IN THE TUBE DURING THE PREPARATION STAGE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO MAJOR DELAYS. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199592 ↗
• MalfunctionMay 15, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, DURING STEP 1, THE HST III SYSTEM (3.8MM) HANDLE WAS SIGNIFICANTLY STIFFER THAN USUAL, BUT THEY CAREFULLY ATTACHED AND ATTEMPTED TO LOAD IT; HOWEVER, THE PROCESS DID NOT FUNCTION PROPERLY AND THE DEVICE BECAME DETACHED, RENDERING IT UNUSABLE. THE PRODUCT WAS SUBSEQUENTLY EXCHANGED FOR A NEW ONE. ACCORDING TO THE PHOTOGRAPH PROVIDED BY THE COMPLAINANT, IT APPEARS THAT THE SEAL GOT STUCK IN THE LOADER. NO PATIENT HARM/EFFECT. THERE WAS ALMOST NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191822 ↗
• MalfunctionMay 7, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) WAS UNUSABLE BECAUSE THE SEAL DID NOT COME OUT DURING SETUP. THE SEAL WAS STUCK INSIDE THE LOADER AND COULDN'T BE REMOVED. A SUBSTITUTE PRODUCT WAS USED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE, AND NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116115 ↗
• MalfunctionApr 29, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) WAS UNUSABLE BECAUSE THE SEAL DID NOT COME OUT DURING SETUP. APPARENTLY, IT REMAINED INSIDE THE LOADER AND COULD NOT BE REMOVED. NO CONTACT WITH THE PATIENT. PRESSED. THE DEVICE DOES NOT TOUCH THE AORTA BECAUSE A SEAL REMAINS INSIDE. A SUBSTITUTE PRODUCT WAS USED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE, AND NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034869 ↗
• MalfunctionApr 28, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT THE HST III SYSTEM (3.8MM) WAS LOADED NORMALLY USING THE DELIVERY DEVICE IN ACCORDANCE WITH THE USAGE GUIDELINES (IFU), BUT A ISSUE OCCURRED WHERE THE SEAL GOT CAUGHT ON THE TIP OF THE LOADER AND COULD NOT BE SMOOTHLY SEPARATED AND INSTALLED. THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW ONE. RELOADING AND INSTALLATION WERE SUBSEQUENTLY SUCCESSFULLY PERFORMED, AND THE REPAIR WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS A PROCEDURAL DELAY OF APPROXIMATELY 7¿8 MINUTES. THERE WAS NO HARM OR ADVERSE EFFECT TO THE PATIENT, AND THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25011310 ↗
• MalfunctionApr 3, 2026Activation Problem

  THE HOSPITAL REPOTED THAT HST III SYSTEM (3.8MM) FAILED TO DEPLOY WHEN SURGEON INTRODUCED IT TO THE AORTATOMY. IT WAS FOUND OUT THAT THE ISSUE WAS THE SEALING CUP WHICH GOES INTO THE AORTA DID NOT OPEN ALL THE WAY TO SEAL OFF BLOOD FROM COMING OUT OF AORTATOMY. NO PATIENT HARM OR INJURY WAS REPORTED. THERE WAS ABOUT FIFTEEN MINUTES DELAY. A NEW DEVICE WAS UTILIZED TO FINISH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773462 ↗
• MalfunctionMar 24, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT DURING THE PREPARATION STAGE, AN ISSUE OCCURRED IN WHICH THE SEAL WAS NOT LOADED STRAIGHT, IT HAS NOT BEEN DEPLOYED PROPERLY INTO THE AORTA. SINCE THERE WERE NO PROBLEMS WITH THE VASCULAR CHARACTERISTICS, A SIDE CLAMP WAS USED. THERE WAS NO DELAY IN THE SURGERY. THERE WAS NO BLOOD LOSS. NO HEALTH HAZARDS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678996 ↗
• MalfunctionMar 19, 2026Fitting Problem

  THE HOSPITAL REPORTED THAT THE SEAL FROM HST III SYSTEM (3.8MM) COULD NOT BE LOADED INTO THE DELIVERY DEVICE, MAKING IT DIFFICULT TO USE. THERE IS NO RISK TO PATIENT HEALTH. NO DELAY WAS REPORTED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636294 ↗

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-2586-2025 · Aug 15, 2025 · Open, Classified
  Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
• Z-2588-2025 · Aug 15, 2025 · Open, Classified
  Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.