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STEALTH® FIBRA® CLAMP INSERT A0G11Recalls & reported problems

Applied Medical Resources Corporation · CLAMP INSERT · 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 00607915114794), received between Aug 1, 2016 and Mar 6, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break1
  • Fitting Problem1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 6, 2017Break; Break

    PLEASE SEE THE ATTACHED REPORT 'AMR2017-03' WITH PICTURES: (ON (B)(6) 2017: DURING PREPARATION OR SURGERY) A MEDICAL STAFF TRIED TO ATTACH THE INSERT TO A CLAMP, HOWEVER; THE INSERT WAS BROKEN EASILY. ANOTHER PACKAGE OF THE INSERT (SAME LOT#) WAS USED FOR PROCEDURE. THIS EVENT DIDN'T AFFECT THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6380527 ↗
  • MalfunctionAug 1, 2016Fitting Problem; Fitting Problem

    "UNKNOWN- IT WAS DURING PREPARATION PRIOR TO CLINICAL USE." "EVENT DESCRIPTION: (ON (B)(6) 2016) DURING PREPARATION PRIOR TO CLINICAL USE;  A NURSE TRIED TO ATTACH THE INSERT TO A CLAMP, HOWEVER; THE INSERT WAS BROKEN UNFORTUNATELY.  THE BROKEN SAMPLE LOT# IS 1250513 OR 1253684. BECAUSE A FEW PACKAGES FROM LOT#1250513 AND LOT#1235684 HAD BEEN OPENED AT THE SAME TIME FOR THE PREPARATION, IT IS DIFFICULT TO IDENTIFY WHICH WAS THE COMPLAINT LOT#.  NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. COMMENTS FROM COSMOTEC： ONE (1) PIECE OF INSERT WAS RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICE AND FOUND THAT THE INSERT PLASTIC PART IS BROKEN. THE SAMPLE WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." TYPE OF INTERVENTION: "UNKNOWN." PATIENT STATUS: "NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5837191 ↗

Other Clamp, Vascular devices

All Clamp, Vascular devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.