HeartString III Proximal Seal HS-3045Recalls & reported problems
Maquet Cardiovascular LLC · HeartString III Proximal Seal · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Maquet HeartString III seal is a clamp used in heart bypass surgery to close an opening in the aorta. Many of its 187 reports describe seals that would not load, fit, or unfold properly, and some describe bleeding that continued. There are 29 injury reports and no deaths. There is 1 open recall, from August 2025, over seals that may not load, deploy, or stop bleeding.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 187
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 00607567700307), received between Jul 14, 2020 and May 7, 2025 — classified as 29 injuries, 158 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (120 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.
Reports received per month
Recalls naming this device
- 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-2586-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fitting Problem120
- Activation Problem38
- Failure to Unfold or Unwrap24
- Insufficient Device Problem Information6
- Break2
- Peeled/Delaminated2
- Activation Failure1
- Activation, Positioning or Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions122
- No Consequences Or Impact To Patient59
- Hemorrhage/Blood Loss/Bleeding13
- Blood Loss1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 187 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2025Peeled/Delaminated; Peeled/Delaminated
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 JAW PEELED OFF DESPITE NOT BEING USED FOR A LONG TIME. IT DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO SIGNIFICANT DELAY. NO HEALTH HAZARDS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21981649 ↗InjuryMay 2, 2025Peeled/Delaminated; Failure to Cut; Peeled/Delaminated; Failure to Cut
MalfunctionMay 1, 2025Melted; Melted
InjuryApr 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
RELATED TO (B)(4). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SEAL (4.5MM) WERE LOADED APPROPRIATELY BUT WERE NOT HEMOSTATIC AT ALL AND BLED MUCH MORE THAN USUAL. THE SEAL WAS REMOVED AND ANOTHER LOADED HS WAS INSERTED. THE SAME SCENARIO OCCURRED AND THE SECOND HS WAS REMOVED. A THIRD WAS INSERTED, AGAIN WITH THE SAME OUTCOME AND A FOURTH WAS INSERTED. THE SURGEON REMOVED THE FOURTH SINCE THERE WAS STILL THE EXCESSIVE BLEEDING AND PLACED A SIDE-BITING CLAMP ON THE AORTA TO COMPLETE THE SINGLE ANASTOMOSIS. ANASTOMOSIS WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 21778525 ↗MalfunctionAug 1, 2023Fitting Problem; Fitting Problem
MalfunctionJul 31, 2023Fitting Problem; Fitting Problem
InjuryJul 10, 2023Activation Problem; Activation Problem
MalfunctionJul 10, 2023Fitting Problem; Fitting Problem
MalfunctionJun 23, 2023Activation Problem; Activation Problem
MalfunctionApr 10, 2023Activation Problem; Activation Problem
MalfunctionFeb 9, 2023Activation Problem; Activation Problem
MalfunctionOct 12, 2022Fitting Problem; Fitting Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE HST III SEAL (4.5MM), 5-PACK SEAL DEVELOPMENT DID NOT GO WELL. THE SEAL COULD NOT BE LOADED INTO THE DELIVERY TUBE AND REMAINED IN THE LOADER AND COULD NOT BE DEPLOYED. THE WHITE PLUNGER IS NOT PRESSED BECAUSE THE SEAL COULD NOT BE DEPLOYED WHEN LOADING IT INTO THE DELIVERY DEVICE. THE BLUE SLIDE IS STILL LOCKED AND NOT UNLOCKED. THE NEW PRODUCT WAS OPENED AND THE OPE WAS SUCCESSFULLY COMPLETED. THE PATIENT HAS NO HEALTH HAZARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15592070 ↗MalfunctionSep 13, 2022Fitting Problem; Fitting Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE HST III SEAL (4.5MM) FELL OFF WHEN THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE LOADING DEVICE. THE BLUE SLIDE WAS LOCKED. SINCE THE SEAL WAS COMPLETELY OUT OF THE DELIVERY TUBE, IT WAS NOT IN CONTACT WITH THE PATIENT'S AORTA. A NEW HSIII WAS ISSUED AND THE OPERATION WAS COMPLETED. THE PATIENT HAD NO HEALTH HAZARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15414323 ↗MalfunctionSep 1, 2022Fitting Problem; Fitting Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE HST III SEAL (4.5MM), WAS NOT PROPERLY LOADED INTO THE DEVICE, PREVENTING IT FROM DEPLOYING. A NEW HEART STRING WAS OPENED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15342168 ↗MalfunctionAug 30, 2022Activation Problem; Activation Problem
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE THE HST III SEAL (4.5MM), WAS USED AND THE HEMOSTATIC SEAL WAS NOT PUSHED OUT OF THE ROTARY DEVICE WHEN THE WHITE PLUNGER BUTTON WAS PRESSED AND PULLED OUT. A NEW DEVICE WAS USED AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS AND THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15325273 ↗MalfunctionAug 23, 2022Fitting Problem; Fitting Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE HST III SEAL (4.5MM), 5-PACK THE SEAL COULD NOT BE LOADED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS USING A SPARE HEART STRING. NO HEALTH HAZARD TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15277971 ↗InjuryJul 20, 2022Fitting Problem; Activation Problem; Fitting Problem; Activation Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, SEAL DID NOT FILL INTO THE TUBE OF THE DELIVERY DEVICE. THE SEAL DID NOT LOAD PROPERLY. AT THE SETTING STAGE, THERE WAS NO SEAL INSIDE THE TUBE. THEY SET IT ACCORDING TO THE PROCEDURE, BUT COULD NOT DO IT MANY TIMES, SO THEY ROLLED THE SEAL BY HAND AND FILLED IT IN THE TUBE AND TRIED TO DEPLOY IT IN THE AORTA, BUT THE SEAL WAS CAUGHT IN THE TUBE AND COULD NOT BE DEPLOYED. THEREFORE, PREPARE AND USE AN ALTERNATIVE HEARTSTRING. THERE WAS A DELAY OF A FEW MINUTES. THERE WAS SOME INCREASE IN BLEEDING, BUT NO ADDITIONAL BLOOD TRANSFUSIONS WERE NEEDED. NO EFFECT ON THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 15071025 ↗MalfunctionJul 15, 2022Fitting Problem; Fitting Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE HST III SEAL DID NOT LOAD CORRECTLY. THEY USED A SECOND DEVICE AND IT WORKED AS INTENDED. THERE WAS NO HARM OR ADVERSE EVENT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15027089 ↗MalfunctionJul 12, 2022Fitting Problem; Fitting Problem
RELATED TO (B)(4). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SEAL (4.5MM), 5-PACK THE SEAL IN THE DELIVERY SHEATH IS TWISTED WHEN PREPARED FOR HS USE AND CANNOT BE LOADED. THE OPERATION WAS COMPLETED WITH NO PROBLEMS USING THE NEW DEVICE AND THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14987717 ↗MalfunctionJul 12, 2022Fitting Problem; Fitting Problem
RELATED TO (B)(4). SUMMARY: THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE AFTER AN HS FAILURE, HST III SEAL (4.5MM), 5-PACK THE SEAL IN THE DELIVERY SHEATH IS KINKED AND CANNOT BE LOADED. THE OPERATION WAS COMPLETED WITH NO PROBLEMS USING THE NEW DEVICE AND THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14987643 ↗MalfunctionJun 29, 2022Activation Problem; Activation Problem
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE USING HST III SEAL (4.5MM), 5-PACK. THEY FOLLOWED THE PROCEDURE, BUT A STICKER (SEAL) REMAINED IN THE DELIVERY DEVICE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14853043 ↗MalfunctionJun 28, 2022Fitting Problem; Fitting Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SEAL (4.5MM), 5-PACK SEAL HAD FALLEN OFF WHEN THE DELIVERY SYSTEM WAS PULLED OUT OF THE LOADING DEVICE. THE OPERATION WAS COMPLETED WITH THE NEW HS#. THE PATIENT HAD NO HEALTH HAZARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14844733 ↗MalfunctionJun 17, 2022Fitting Problem; Audible Prompt/Feedback Problem; Fitting Problem; Audible Prompt/Feedback Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE HST III SEAL (4.5MM), 5-PACK, THE SEAL WAS NOT LOADED AND REMAINED IN THE LOADER, MAKING IT UNUSABLE, SO THE NEW ITEM WAS OPENED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PROBLEM FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734394 ↗InjuryMay 16, 2022Activation Problem; Activation Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING HST III SEAL (4.5MM). THERE WAS NO CALCIFICATION AND LOADING WAS PERFORMED AS USUAL, BUT BLEEDING WAS ABNORMALLY LARGE AND IT BECAME A PROCEDURE TO SWITCH TO THE SIDE CLAMP. THE AMOUNT OF BLEEDING WAS NOT THE AMOUNT THAT REQUIRED A BLOOD TRANSFUSION. THE SEAL WAS DEPLOYED IN THE AORTA, BUT THE BLEEDING WAS SEVERE, WHETHER THE SEAL WAS IN A BAD SHAPE OR IN A BAD POSITION. IT IS CLEARLY DIFFERENT FROM WHEN THEY USE IT ALL THE TIME, AND IT SEEMS THAT THE PRODUCT IS DEFECTIVE. THE NEW HEART STRING IS NOT USED AND IT IS SUPPORTED BY THE SIDE CLAMP. NO HARM TO THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14409048 ↗MalfunctionMay 10, 2022Fitting Problem; Fitting Problem
THE HOSPITAL REPORTED THAT AT THE TIME OF OPENING HST III SEAL (4.5MM), 5-PACK, THE SEAL WAS NOT IN THE NORMAL POSITION AND IT WAS NOT READY FOR LOADING, SO THEY DID NOT USE IT FOR THE PATIENT AND FINISHED THE SURGERY WITH A NEW PRODUCT. THE SEAL DID NOT FIT PROPERLY AFTER OPENING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14347549 ↗
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, ClassifiedHeartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
- Z-2588-2025 · Aug 15, 2025 · Open, ClassifiedHeartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Other Clamp, Vascular devices
- Heartstring III System 3.8MM HSK-3038Maquet Cardiovascular LLC · Clamp, Vascular1 recall4 deaths809 reports
- Heartstring III System 4.3MM HSK-3043Maquet Cardiovascular LLC · Clamp, Vascular1 recall265 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR284 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR256 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR67 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR65 reports
- Flo-Thru Intraluminal Shunt® FT-12225Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
- Flo-Thru Intraluminal Shunt® FT-12125Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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