A&E Medical / Rotating Surgical PunchesRecalls & reported problems across all models
A & E Medical Corporation · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 73
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 10 models of A&E Medical / Rotating Surgical Punches by A & E Medical Corporation in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between May 10, 2019 and Dec 8, 2025 — classified as 6 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (27 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported A&E Medical / Rotating Surgical Punches problems
Device problems
- Packaging Problem27
- Contamination /Decontamination Problem16
- Failure to Cut8
- Mechanical Problem8
- Dull, Blunt7
- Device Contaminated During Manufacture or Shipping4
- Physical Resistance/Sticking4
- Defective Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- Laceration(s)3
- Unspecified Tissue Injury3
- No Known Impact Or Consequence To Patient2
- Perforation of Vessels2
- Excessive Tear Production1
- Great Vessel Perforation1
- Hemorrhage/Blood Loss/Bleeding1
A&E Medical / Rotating Surgical Punches models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- A&E Medical / Rotating Surgical Punches 080-401Punch, Surgical29 reports
- A&E Medical / Rotating Surgical Punches 080-351Punch, Surgical17 reports
- A&E Medical / Rotating Surgical Punches 080-403Punch, Surgical10 reports
- A&E Medical / Rotating Surgical Punches 080-271Punch, Surgical6 reports
- A&E Medical / Rotating Surgical Punches 080-451Punch, Surgical3 reports
- A&E Medical / Rotating Surgical Punches 080-481Punch, Surgical3 reports
- A&E Medical / Rotating Surgical Punches 080-501Punch, Surgical2 reports
- A&E Medical / Rotating Surgical Punches 080-453Punch, Surgical1 report
- A&E Medical / Rotating Surgical Punches 080-483Punch, Surgical1 report
- A&E Medical / Rotating Surgical Punches 080-402Punch, Surgical1 report
Recent A&E Medical / Rotating Surgical Punches adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED DURING THE PROCEDURE, THE SURGEON USED THE DEVICE TO PREPARE THE PROXIMAL OPENING IN THE AORTA FOR THE GRAFT. HOWEVER, THE PUNCH FAILED TO MAKE A SUFFICIENT HOLE. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23752631 ↗MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656576 ↗MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PUNCH DOES NOT CREATE A CIRCULAR HOLE. AS IT IS RETRACTED, IT TENDS TO FLAKE/FRAY THE AORTA. HOSPITAL REPORTED THAT THERE WAS NO DAMAGE TO THE PATIENT OR OTHER USER. THERE WAS NO SURGICAL DELAY FOUND. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22286614 ↗MalfunctionJun 18, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Tissue Injury
MAUDE report 22286613 ↗MalfunctionJun 6, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PUNCH DOES NOT CREATE A CIRCULAR HOLE. AS IT IS RETRACTED, IT TENDS TO FLAKE/FRAY THE AORTA. HOSPITAL REPORTED THAT THERE WAS NO DAMAGE TO THE PATIENT OR OTHER USER. THERE WAS NO SURGICAL DELAY FOUND. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22158921 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143727 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143722 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143715 ↗MalfunctionJun 4, 2025Contamination /Decontamination Problem; Packaging Problem; Contamination /Decontamination Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143711 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143710 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143703 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143308 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143301 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143259 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143256 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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