FASSIER-DUVAL TELESCOPIC IM SYSTEM MR320Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07540194013095), received between Mar 4, 2026 and Jun 17, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJun 17, 2026Difficult to Open or Close

  THE DISTRIBUTOR FROM (B)(6) REPORTED THAT THE MALE RETRIEVER (MR300) COULD NOT BE DISASSEMBLED AFTER SURGERY. THE HANDLE ASSEMBLY, TUBE, AND COIL-PULLER COULD NOT BE REMOVED, THE RELEASE KEY COULD NOT BE INSERTED, AND THE MECHANICAL ASSEMBLY WAS LOOSE. INSERTION OF THE TORQUE HANDLE DID NOT ALLOW ROTATION. THE EVENT RESULTED IN A DELAY OF MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533489 ↗
• InjuryMar 4, 2026Device Handling Problem

  A HOSPITAL REPRESENTATIVE FROM THE UNITED KINGDOM REPORTED AN ISSUE INVOLVING A MALE RETRIEVER HANDLE (MR300). SPECIFICALLY, HE STATED THAT TWO MECHANICAL SCREWS WERE MISSING AND THE RATCHET MECHANISM WAS NOT FUNCTIONING.

  Patient problems: Bone Fracture(s)

  MAUDE report 24506262 ↗