SharkCore DSC-22-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00855208005087), received between Apr 24, 2017 and Nov 4, 2025 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COIL ON THE BALLOON CAME APART, AND PART OF THE COIL WAS LEFT IN THE PATIENT AND REQUIRED RETRIEVAL. THE PATIENT HAD A SMALL TEAR IN THE ESOPHAGUS.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 23465303 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH FINAL DIAGNOSIS OF ISTHMIC PANCREATIC SOLID 2.7 CM LESION, HISTOLOGY ONGOING HAD INTRALUMINAL BLEEDING, INTRA-PROCEDURAL HEMOSTASIS WITH 1 CLIP DURING 1 PASS PULL-THROUGH EUS-FNB PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21343864 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH FINAL DIAGNOSIS OF TAIL PANCREATIC SOLID-CYSTIC MIXED 2CM LESION, SCHWANNOMA HAD INTRALUMINAL BLEEDING, INTRA-PROCEDURAL HEMOSTASIS WITH 1 CLIP DURING 2 PASSES EUS-FNB PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21343815 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT DIED AFTER A FINE NEEDLE ASPIRATION PROCEDURE. PATIENT WAS ADMITTED THE DAY AFTER BEACON FNA 22G 1 PASS PROCEDURE CYST EMPTYING DUE TO FULMINANT ACUTE PANCREATITIS. PATIENT DIED THE FOLLOWING DAY AFTER ADMITTED, WITH MULTI-ORGAN FAILURE. PATIENT FINAL DIAGNOSIS ATYPIC SIMPLE CYST (CYTOHISTOLOGIC AND LAB NEGATIVE FOR CANCER) OF PANCREAS/MESENTERY. IMMEDIATE MANAGEMENT FOR FULMINANT ACUTE PANCREATITIS AND COMORBIDITY OF HYPERTENSION (IN TARGET WITH TREATMENT), MEDITERRANEAN ANEMIA TRAIT (NORMAL HGB LEVELS), NO CONCOMITANT TREATMENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21152967 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FINE NEEDLE BIOPSY (FNB) 22G 2 PASSES, PATIENT HAD BLEEDING WITH CLIPS AND ADRENALINE USED FOR MANAGEMENT. INTRALUMINAL BLEEDING, INTRA-PROCEDURAL HEMOSTASIS WITH 1:20,000 ADRENALINE SOLUTION 4ML AND 2 CLIPS. PATIENT FINAL DIAGNOSIS HEAD PANCREATIC SOLID-CYSTIC MIXED 3, 2CM LESION-MICROCYSTIC ADENOMA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21137987 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FINE NEEDLE BIOPSY (FNB) 22G 1 PASS PROCEDURE, PATIENT WAS ADMITTED 10 DAYS FOR POST PROCEDURAL PAIN, FREE FLUID COLLECTION OUTRIGHTED IN CT SCAN. NO COMORBIDITY, PATIENT WILL UNDERGO SURGERY OF THE LESION (DCP).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21137940 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FINE NEEDLE BIOPSY (FNB), A PATIENT HAD SELF LIMITED INTRALUMINAL BLEED. PATIENT HAD TWO EUS-FNB PROCEDURES, 22G 3 PASSES ON (B)(6)2024 AND 22G 1 PASS LOW-PULL ON (B)(6)2024. IN BOTH PROCEDURES, PROLONGED SELF-LIMITING INTRALUMINAL BLEEDING, REPORTED AS LASTING MORE THAN USUAL BUT NO HEMOSTATIC PROCEDURE CARRIED OUT. NO COMORBIDITIES AND NO CONCOMITANT TREATMENTS. FINAL DIAGNOSIS SOLID 2CM PANCREATIC TAIL MASS, FINAL DIAGNOSTIC AT SECOND FNB OF ADENOCARCINOMA POORLY DIFFERENTIATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21137826 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FINE NEEDLE BIOPSY (FNB) AND FINE NEEDLE ASPIRATION (FNA) PROCEDURE, A PATIENT HAD A COMPLICATION OF PANCREATITIS AND SEVERE BLEEDING WHICH LED TO EXTENDED HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21137741 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPLICATIONS OCCURRED AFTER PERFORMING FINE NEEDLE BIOPSY (FNB) 22G 2 PASSES WITH 2 NEEDLES (LN + FREE FLUID). PATIENT HAD MASSIVE HEMORRHAGE. PATIENT WAS ON ANTIAGGREGANT TREATMENT-LOW MOLECULAR WEIGHT HEPARIN AS PER NOTES IN ATTACHED LIST; PHYSICIAN SEEMED TO THINK THAT THE PATIENT RECEIVED ABOUT 4000U THE NIGHT PRIOR TO THE CASE. FINAL DIAGNOSIS OF ADENOPATHY WITH TB. LATE MASSIVE HEMORRHAGE, PROLONGED ADMISSION (STILL HOSPITALIZED EARLY (B)(6) 2025), IC TRANSFERAL, 3 URGENT ENDOSCOPY PROCEDURES, 2 INTERVENTIONAL RADIOLOGY AND 2 SURGICAL OPERATIONS TO CONTROL THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21137594 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPLICATIONS OCCURRED AFTER PERFORMING FINE NEEDLE BIOPSY (FNB) AND FINE NEEDLE ASPIRATION (FNA) PROCEDURE. THE COMPLICATIONS INCLUDED SEVERE BLEEDING AND PANCREATITIS. THE PATIENT HAD AN EXTENDED HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 21137580 ↗
• MalfunctionFeb 2, 2023Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, THE ORANGE HANDLE ON THE DEVICE BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284390 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, A TOTAL OF 143 PATIENTS HAVING 151 PANCREATIC LESIONS WERE ANALYZED. 69 PATIENTS USED SHARK-CORE WHILE 74 PATIENTS USED PRO-CORE. 74 LESIONS WERE BIOPSIED IN SHARK-CORE GROUP FROM 69 PATIENTS. FOUR PATIENTS HAD THEIR PROCEDURE REPEATED. 2 PATIENTS DEVELOPED MILD PANCREATITIS AND ONE REQUIRED ADMISSION WITH EPIGASTRIC PAIN AND VOMITING.

  Patient problems: Abdominal Pain; Pancreatitis; Vomiting

  MAUDE report 12744450 ↗
• InjuryAug 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED SEPTEMBER 2019 AND DECEMBER 2019, PATIENTS FOUND TO HAVE PANCREATIC MASSES DURING IMAGING WERE RANDOMLY ASSIGNED TO GROUPS FROM WHOM PANCREATIC TISSUE SAMPLES WERE COLLECTED USING REVERSE-BEVEL, MENGHINI-TIP, FRANSEEN AND GAUGE 22 FORK-TIP NEEDLES. THE PATIENT HAD POST-PROCEDURE ABDOMINAL PAIN WHICH REQUIRED AN EMERGENCY ROOM VISIT.

  Patient problems: Abdominal Pain

  MAUDE report 10411902 ↗
• MalfunctionFeb 11, 2020Failure to Advance

  DR MADE ONE PASS WITH FNB NEEDLE WITHOUT PROBLEM. DURING THE SECOND PASS, THE NEEDLE WOULD NOT ADVANCE. STAFF REMOVED THE NEEDLE FROM THE SCOPE AND THE NEEDLE ADVANCED. NEEDLE WAS REINSERTED AND THE NEEDLE WOULD NOT ADVANCE WHEN IN THE SCOPE. A NEW NEEDLE WAS OPENED AND WAS USED WITHOUT PROBLEM AND NO HARM CAME TO THE PATIENT. THE REP WAS NOTIFIED BY STAFF. MANUFACTURER RESPONSE FOR BIOPSY NEEDLE, SHARKCORE (PER SITE REPORTER). DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. AWAITING REPLY FROM MANUFACTURER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9693749 ↗
• InjuryMay 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED 2018, THE PATIENT UNDERWENT INITIAL ESOPHAGEAL UPPER SPHINCTER GUIDED LIVER BIOPSY USING TO DIFFERENT NEEDLES. THE PATIENT EXPERIENCED PAIN AFTER THE PROCEDURE BUT WAS DISCHARGED WITHOUT PAIN. AFTER ONE DAY OF THE PROCEDURE. DURING A FOLLOW-UP CALL, THE PATIENT REPORTS PAIN AND WAS INSTRUCTED TO GO TO THE EMERGENCY DEPARTMENT. THE LABORATORY TESTING SHOWED STABLE HEMOGLOBIN AND THE CT SCAN SHOWED NO VISIBLE HEMORRHAGE, PERFORATION OR ABSCESS. THE PATIENT WAS SENT HOME AND DID NOT REPORT PAIN DURING THE 7 DAY FOLLOW-UP CALL.

  Patient problems: Pain; Radiation Exposure, Unintended

  MAUDE report 8639307 ↗
• 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 8294710 ↗
• InjuryApr 24, 2017Detachment Of Device Component; Detachment Of Device Component

  ADDITIONAL INFORMATION RECEIVED. THE TREATING PHYSICIAN CONFIRMED THE PATIENT DID NOT NEED ANY ADDITIONAL BLOOD TRANSFUSIONS AND THE PATIENT IS STABLE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 6515429 ↗