Morpheus 06507212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787065072120), received between Oct 10, 2017 and Jan 29, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K051655); they may or may not involve this specific model.

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

Recent adverse event reports

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

• InjuryJan 29, 2019Fracture; Fracture

  CUSTOMER REPORTED A SIGNIFICANT SECTION OF THE MORPHEUS CT GUIDEWIRE (11 CM) BROKE OFF DURING A PROCEDURE CAUSING A PATIENT TO HAVE TO GO INTO EMERGENCY OR SURGERY TO REMOVE THE PIECE. GUIDEWIRE AND CATHETER WERE PLACED IN PERIAPPENDICEAL ABSCESS IN RLQ OF ABDOMEN. AS GUIDEWIRE WAS BEING REMOVED, FLOPPY TIP OF WIRE SHEARED OFF AND REMAINED IN PATIENT. SURGERY REMOVED GUIDEWIRE PIECE AND PATIENT WAS STABLE AFTERWARDS. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8286810 ↗
• InjuryOct 10, 2017Knotted; Knotted

  AS REPORTED TO ANGIODYNAMICS ON SEPTEMBER 18, 2017: RN INSERTED WIRE INTO PATIENT AND MET RESISTANCE. WHEN THE DR. TRIED TO WITHDRAW THE GUIDEWIRE AND NEEDLE, THE NEEDLE CAME OUT, BUT THE WIRE WAS STUCK. THE WIRE THEN BEGAN TO UNCOIL. THE PATIENT WAS TAKEN TO THE OR TO HAVE WIRE REMOVED. IT WAS REPORTED THE WIRE WAS SUCCESSFULLY REMOVED VIA CUTDOWN. UPON REMOVAL OF THE GUIDEWIRE, IT WAS NOTED THE GUIDEWIRE HAD KNOTTED. IT WAS REPORTED THERE WAS NO DAMAGE TO THE VESSEL DUE TO THE EVENT. IT WAS INDICATED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6935055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051655. One submission often covers many models, so check the product and lot details in each record.

• Z-0418-2021 · Oct 14, 2020 · Terminated
  Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H7870
• Z-0773-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046
• Z-0774-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050
• Z-0778-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular s
• Z-0776-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 0659
• Z-0775-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051
• Z-0777-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 0659
• Z-0772-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 0659703
• Z-1405-2013 · Apr 30, 2013 · Terminated
  AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standar