SCANLAN® A/V Punch 1001-610Recalls & reported problems
Scanlan International Inc · SCANLAN® A/V Punch, 6.0 x 2.0 mm (Elliptical) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846159000924), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Jam” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2025Mechanical Jam; Mechanical Jam
"DURING A LIVE DONOR KIDNEY TRANSPLANT, THE AORTIC PUNCH DID NOT CUT PROPERLY AND TORE THE ARTERY". AS REPORTED. A YOUNG PATIENT UNDERWENT A KIDNEY TRANSPLANT FROM A LIVING DONOR. DURING THE SURGERY, AN ARTERIOTOMY WAS PERFORMED, AND THE SCANLAN AORTIC PUNCH WAS USED. HOWEVER, THE DEVICE FAILED TO FUNCTION PROPERLY AND BECAME JAMMED, CAUSING SIGNIFICANT DAMAGE TO THE EXTERNAL ILIAC ARTERY. AS A RESULT, RESECTION OF THE DAMAGED ARTERIAL SEGMENT WAS REQUIRED, FOLLOWED BY THE PLACEMENT OF A PTFE VASCULAR GRAFT AND ANASTOMOSIS OF THE KIDNEY GRAFT ONTO THIS PROSTHETIC GRAFT. DESPITE THESE MEASURES, ADEQUATE BLOOD FLOW COULD NOT BE ESTABLISHED, AND A NEPHRECTOMY OF THE TRANSPLANTED KIDNEY WAS NECESSARY.
Patient problems: Perforation of Vessels
MAUDE report 22204556 ↗
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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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