Amplatz G28781Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002287815), received between Sep 21, 2018 and Apr 19, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2024Unraveled Material; Unraveled Material

  AS REPORTED, DURING AN INFERIOR VENA CAVA (IVC) FILTER RETRIEVAL PROCEDURE, THE TIP OF AN AMPLATZ STIFF SUPPORT WIRE GUIDE UNRAVELED. ACCESS WAS OBTAINED AT THE INTERNAL JUGULAR (IJ) VEIN TO TARGET THE INFERIOR VENA CAVA (IVC). THE PATIENT'S ANATOMY WAS NOT STENOSED, TORTUOUS, CALCIFIED OR SCARRED. THE WIRE WAS NOT ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE AND RESISTANCE WAS NOT FELT UPON INSERTION OF THE WIRE. UPON REMOVAL OF THE WIRE THROUGH AN UNSPECIFIED SHEATH, THE "DISTAL FLOPPING TIP OF THE WIRE CASING UNCOILED". THE WIRE WAS REMOVED FROM THE STERILE FIELD AND ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. THE WIRE WAS NOT MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT DURING THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142167 ↗
• MalfunctionJun 26, 2020Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  UPON REVIEW OF INITIAL DFAF, PERFORMED (B)(6) 2020, THE WIRE GUIDE WAS FOUND TO BE SEPARATED AND ELONGATED. THE SAFETY WIRE WAS ALSO EXPOSED. NO DELAMINATION WAS MENTIONED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201746 ↗
• MalfunctionSep 21, 2018Structural Problem

  THE COMPLAINANT REPORTED THAT THE PROCEDURE WAS FOR ILIAC STENTING FROM A CONTRALATERAL PUNCTURE SITE, BUT THE END OF THE AMPLATZ STIFF SUPPORT WIRE GUIDE WAS ¿VERY FLOPPY.¿ IT WAS FURTHER NOTED THAT THE ANCHOR SOLDER WAS SEPARATED FROM THE INNER MANDREL WIRE WHICH RESULTED IN COIL ELONGATION. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7897948 ↗