Aortic Cutter 4.3MM AC-3043Recalls & reported problems
Maquet Cardiovascular LLC · Aortic Cutter 4.3MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607567700277), received between Sep 21, 2020 and Sep 13, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IN THE COURSE OF AN ONLINE PRIMARY MARKET RESEARCH THE RESPONDENT STATED THE FOLLOWING: IN PERFORMING OFF-PUMP CABG PROCEDURES (OPCAB), THE FOLLOWING HEARTSTRING III WITH AORTIC CUTTER 4.3MM (GETINGE) WAS PERSONALLY USED IN THE PAST 12 MONTHS. RATE LEVEL OF AGREEMENT WITH THE FOLLOWING STATEMENT AS IT RELATES TO HEARTSTRING III WITH AORTIC CUTTER 4.3MM (GETINGE). THE HEARTSTRING III SEAL PROVIDES ADEQUATE HEMOSTASIS NEEDED TO COMPLETE THE PROXIMAL ANASTOMOSIS. COMMENTS: THE HEMOSTATIC EFFECT IS UNSATISFACTORY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15414325 ↗MalfunctionApr 8, 2022Mechanical Problem; Mechanical Problem
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE AORTIC CUTTERS, 5-PACK (4.3MM) UNLOCK BUTTON WAS HARDER THAN USUAL. THEY DIDN'T USE IT JUST IN CASE, BUT THEY OPENED A NEW PRODUCT OF THE SAME SIZE AND COULD USE IT WITHOUT ANY PROBLEM. THERE IS NO DAMAGE TO THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14051122 ↗MalfunctionSep 21, 2020Break; Break
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AORTIC CUTTERS, 5-PACK (4.3MM) BODY BROKE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10563807 ↗
Other Cutter, Surgical devices
- NA 214646Medos International Sàrl · CUTTER, SURGICAL361 reports
- Sklar Instruments 96-2666ASklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2666Sklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2671ASklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2667Sklar Corporation · CUTTER, SURGICAL1 recall0 reports
- NA 214605Medos International Sàrl · CUTTER, SURGICAL17 reports
- NA 388.750Synthes GmbH · CUTTER, SURGICAL14 reports
- Aortic Cutter 3.8MM AC-3038Maquet Cardiovascular LLC · Cutter, Surgical12 reports
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
- 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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