Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™ 1001-572Recalls & reported problems
Scanlan International Inc · Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™- Midi Straight (yellow), clamping pressure 75-80 g (2/sterile pkg) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846159000818), received between Feb 6, 2026 and Feb 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Patient-Device Incompatibility
SCANLAN WAS CONTACTED REGARDING A VASCU STAT PLUS NOT FULLY FUNCTIONING. THE END USER STATED ON 01/09/2026, THERE WAS A PROBLEM WITH THE VASCU STAT PLUS 1 X 1001-572 (LOT #: 8204001). THE HOSPITAL REPORTED THAT DURING THE CASE THE BULLDOG CLAMP DIDN'T CLOSE FULLY ON THE TIP. THEY HAD TO USE ANOTHER BULLDOG CLAMP. IT WORKED WITHOUT ANY PROBLEM AND THERE WAS NO HARM TO THE PATIENT. SINCE THEORETICALLY A NOT FULLY CLOSED BULLDOG CAN LEAD TO A PATIENT PROBLEM, THE HOSPITAL DECIDED TO REPORT THIS EVENT AS A VIGILANCE CASE TO SWISS MEDIC. ADDITIONAL INFORMATION RECEIVED 1/14/2026 THE SURGEON WAS APPLYING THE CLAMP TO THE INTERNAL MAMMARY ARTERY, AND WHEN THE SURGEON RECOGNIZED BLEEDING ON THE CLAMP SIDE, HE USED A NEW CLAMP WITHOUT ANY ISSUE. HE STATED THAT THE CLAMPING PRESSURE WAS NOT ENOUGH TO PROPERLY OCCLUDE THE VESSEL. THE TIPS OF THE FOAM CLAMP JAWS WERE MORE OPEN, AND THE CLAMP JAWS DID NOT FULLY CLOSE AND OCCLUDE THE VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283745 ↗
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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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