Stealth® Clamps A3220Recalls & reported problems
Applied Medical Resources Corporation · Vascular Clamp, Reusable · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915114237), received between Dec 12, 2018 and Jul 31, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Slipped1
- Failure to Seal1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2025Device Slipped; Failure to Seal; Device Slipped; Failure to Seal
PROCEDURE PERFORMED: CARDIO THORACIC PROCEDURE. EVENT DESCRIPTION: IT WAS REPORTED BY THE CONSULTANT SURGEON THAT THE CLAMP WAS SLIPPING OF THE AORTA DURING THE CASE. CASE COMPLETED WITH ANOTHER CLAMP. CASE COMPLETED AND NO INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT. INTERVENTION: CASE COMPLETED WITH ANOTHER CLAMP. PATIENT STATUS: CASE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22681317 ↗MalfunctionDec 12, 2018Mechanical Problem; Mechanical Problem
PROCEDURE PERFORMED: AORTA. DR. HAD TO CLAMP THE AORTA BUT THE COVER OF THE CLAMP MISALIGNED, PREVENTING THE USE. THIS UNIT WAS SHIPPED TO THEM, NEW, LAST SEPTEMBER SO PLEASE CHECK THE ORIGINAL ORDER BECAUSE THEY DO NOT HAVE THE DETAILS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM APPLIED MEDICAL REP 16NOV2018: LOT. NUMBER CONFIRMED TO BE 1309873. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8158304 ↗
Other Clamp, Vascular devices
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- Heartstring III System 4.3MM HSK-3043Maquet Cardiovascular LLC · Clamp, Vascular1 recall265 reports
- 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.