SCANLAN® 2002-16Recalls & reported problems
Scanlan International Inc · SCANLAN® Multi-Purpose Clamp · Class 2
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846159007442), received between Mar 22, 2024 and Jun 11, 2024 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Reperfusion Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
"DURING CABG, WHILE AORTA WAS CLAMPED WITH GROSS CLAMP, IT SUDDENLY BROKE BY ITS SELF. SURGEON WAS NOTIFIED AND IT WAS REMOVED FROM THE OPERATING FIELD." AS REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19515622 ↗DeathMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A CARDIOVASCULAR SURGERY (ASCENDING AORTA SURGERY AND AORTIC VALVE PLASTY), THE AORTIC CLAMP BROKE AT THE LEVEL OF ONE OF THE TWO JAWS, CAUSING AN UNEXPECTED REPERFUSION OF A VASCULAR SECTOR CONTAINING AIR AND THUS THREATENING THE PATIENTS VITAL PROGNOSIS. UNFORTUNATELY, THE PATIENT DIED.
Patient problems: Reperfusion Injury
MAUDE report 18960893 ↗
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- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR284 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR256 reports
- HeartString III Proximal Seal HS-3045Maquet Cardiovascular LLC · Clamp, Vascular1 recall187 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.