SharkCore DSC-25-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855208005094), received between Jan 31, 2019 and Jul 13, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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

Recent adverse event reports

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

• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN (B)(6) 2018 AND (B)(6) 2019, ONE PATIENT HAD INTRA-PROCEDURAL PERITONEAL BLEEDING WITH A 4 G/DL HEMOGLOBIN LEVEL DROP AFTER THE EUS-FNB (ENDOSCOPIC ULTRASOUND FINE-NEEDLE BIOPSY PROCEDURE). THE PATIENT WAS A RENAL CANCER SAMPLED METASTASIS SAMPLED WITH A 25-GAUGE FORK-TIP NEEDLE. THE PATIENT WAS HOSPITALIZED BUT NO BLOOD TRANSFUSIONS WERE REQUIRED.

  Patient problems: No Code Available

  MAUDE report 10264918 ↗
• MalfunctionJan 31, 2019Difficult to Insert; Retraction Problem; Difficult to Insert; Retraction Problem

  ACCORDING TO THE REPORTER, THE FIRST PASS WAS DONE CORRECTLY AND THE NEEDLE WAS EXTRACTED FROM THE SHEATH TO REMOVE THE SAMPLE, BUT, IT WAS NO LONGER POSSIBLE TO REINSERT THE NEEDLE. THE NEEDLE WAS NOT FOLDED, BUT, IT BLOCKED THE HEIGHT OF THE HAND PIECE AND THE SAFETY SHEATH DIS NOT LOCK IN PLACE. THE INCIDENT OCCURRED ON THE FIRST NUMBER PASS AND THEY CHANGED THE NEEDLE TO CORRECT THE PROBLEM. THERE WAS NO PATIENT INJURY. A REPEAT PROCEDURE WAS NECESSARY BUT THERE WAS NO EXTENDED HOSPITALIZATION OR MEDICAL OR SURGICAL INTERVENTION NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294730 ↗