AESCULAP FV002RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04041906131975), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2022Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED TO AESCULAP AG THAT A TUNNELING INSTRUMENT 300MM (PART # FV002R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE TIP DID NOT PENETRATE DURING SURGERY. DURING THE VP SHUNT OPERATION, THE PHYSICIAN TRIED TO INSERT A TUNNELER FROM THE BACK OF THE PINNA TO THE CLAVICLE, BUT IT DID NOT PENETRATE. THE DEVICE TIP REMAINED IN-SITU. THE SURGEON ATTEMPTED TO REMOVE THE TIP, BUT WAS NOT ABLE TO REMOVE IT AND DECIDED TO REMOVE IT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655284 ↗