Delta® 25132-5 (UDI 00643169466418)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169466418), received between Jun 15, 2017 and Dec 15, 2022 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

5 other recalls cover devices cleared under the same FDA submission (K902783); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2022Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A DELTA DIVERTER VALVE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LATERAL VENTRICULOPERITONEAL SHUNT ON (B)(6) 2021 DUE TO HYDROCEPHALUS 3 MONTHS AFTER CRANIOTOMY AND BONE FLAP REMOVAL. IT WAS REPORTED THAT THERE WAS POOR HEALING OF THE POSTERIOR OCCIPITAL INCISION AFTER 1 YEAR OF THE OPERATION. ON (B)(6) 2022 THE ABDOMINAL END OF THE SHUNT PUMP WAS FOUND TO RUPTURED AND CSF WAS LEAKING. TO AVOID TRIGGERING INTRACRANIAL INFECTION, CONTRALATERAL VENTRICULOPERITONEAL SHUNT WAS PERFORMED ON (B)(6) 2022. THE SITE REPLACED THE SHUNT AND ACCESSORIES.

  Patient problems: Cerebrospinal Fluid Leakage; Impaired Healing

  MAUDE report 15987659 ↗
• MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT WAS BEING IMPLANTED WITH THE SHUNT, AND WHILE CHECKING THE PERFORMANCE OF THE VALVE DURING THE PROCEDURE, THE PHYSICIAN RECOGNIZED SOME CEREBROSPINAL FLUID LEAKAGE FROM THE VALVE. AS A RESULT, THE VALVE WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12175061 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "INADVERTENT FELL DOWN AND HEAD TRAUMA." PREOPERATIVE DIAGNOSIS WAS SKULL FRACTURE, HYDROCEPHALUS, AND CEREBELLAR SUBDURAL HEMATOMA. IN ORDER TO REDUCE INTRACRANIAL PRESSURE, THE PATIENT WAS SENT TO THE OPERATING ROOM UNDER GENERAL ANESTHESIA ON (B)(6) 2020, TO PERFORM VENTRICLE-VENTRICULAR ABDOMINAL SHUNT SURGERY, THE OPERATION PROCESS WAS SMOOTH, THE CEREBROSPINAL FLUID WAS DRAINED SMOOTHLY, THE INTRACRANIAL PRESSURE WAS REDUCED, AND THE RELATED SYMPTOMS WERE IMPROVED. ON (B)(6) 2020, THE NURSE ON DUTY CHECKED THE SKIN AND FOUND THAT THE LOCAL SCALP WOUND AROUND THE DRAINAGE SHUNT TUBE IMPLANTED IN THE HEAD SHOWED OBVIOUS REDNESS AND SWELLING, BUT THERE WAS NO EXUDATE. THE BLOOD INFECTION INDEX WAS NOT OBVIOUS AFTER RECHECK. IN THE NEXT FEW DAYS, THE REDNESS AND SWELLING GRADUALLY INCREASED. AFTER A DOCTOR'S EXAMINATION, THE SCALP WOUND WAS STRENGTHENED WITH LOCAL DRESSING, AND A LITTLE HORMONE ANTI-ALLERGIC TREATMENT WAS ADDED, AND THE WOUND GRADUALLY HEALED. ADDITIONAL INFORMATION RECEIVED STATED THAT IT WAS SUSPECTED THAT PATIENT FACTORS CAUSED THE PROBLEM, AND LOCAL DRESSING CHANGES HAD BEEN STRENGTHENED. AT

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 10871513 ↗
• MalfunctionNov 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10818279 ↗
• MalfunctionJul 20, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE VALVE WAS TESTED PRIOR TO USE AND DID NOT WORK BECAUSE OF REFLUX PROBLEM. AS A RESULT THE DEVICE WAS REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE REFLUX PROBLEM WAS NOT DETERMINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10299230 ↗
• MalfunctionJul 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10268478 ↗
• MalfunctionJul 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE VALVE LEAKED INTRA-OPERATIVELY. IT WAS NOTED THERE WAS NO PATIENT INVOLVEMENT AS THEY WERE NOT IMPLANTED WITH THE VALVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10242333 ↗
• MalfunctionOct 7, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR DISCOVERED A HOLE IN THE DELTA CHAMBER. THE OPERATION WAS POSTPONED, AND THE PATIENT WAS SAFE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9163764 ↗
• MalfunctionSep 6, 2019Break; Break

  IT WAS REPORTED THAT THE SHUNT WAS DAMAGED INTRA-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8971403 ↗
• InjuryAug 7, 2019Disconnection; Disconnection

  MEDTRONIC RECEIVED A REPORT THAT SHUNT TUBE WAS DETACHED. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE OPERATING ROOM UNDER THE GENERAL ANESTHESIA FOR ENDOSCOPIC VENTRICULO-PERITONEAL SHUNT + VENTRICULAR CHOROID PLEXUS CAUTERIZATION + INTRACRANIAL DECOMPRESSION; INTRAOPERATIVE SUCCESSFUL PUNCTURE OF THE RIGHT VENTRICLE FRONTAL ANGLE. THE BRAIN PRESSURE WAS SLIGHTLY HIGH, THE CEREBROSPINAL FLUID WAS COLORLESS AND CLEAR, AND THE SHUNT DEVICE WAS CONNECTED. THE ABDOMINAL CAVITY END WAS PLACED UNDER THE XIPHOID PROCESS ABOUT 30 CM, AND THE WHOLE PROCESS WAS SMOOTH. NEXT DAY, THE PHYSICIAN SAW THAT THE SHUNT VALVE WAS PRESSED SMOOTHLY, AND THE HEAD DRAINAGE TUBE WAS UNOBSTRUCTED. ON (B)(6) 2019, THE DOCTOR FOUND THAT THE DIVERTING VALVE PRESS COULD TOUCH THE SUBCUTANEOUS SWELLING, THE TRACHEOTOMY SLEEVE WAS UNOBSTRUCTED, AND THE VALVE SHUNT TUBE WAS DETACHED. THE EXPLORING EMERGENCY SURGERY WAS PLANNED TO PERFORM, AND THE FAMILY MEMBERS WAS EXPLAINED THE CONDITION AND THE FAMILY MEMBERS SIGNED THE CONSENT TO THE SURGICAL EXPLORATION AND ARRANGED THE OPERATION. ON (B)(6) 2019, THE PATIENT WAS SENT TO THE OPERATING ROOM. UNDER THE GENERAL ANESTHESIA, THE PATIENT UNDERWENT VENTRICU

  Patient problems: Swelling

  MAUDE report 8871964 ↗
• MalfunctionAug 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER THE CLINICIAN IMPLANTED THE VALVE DURING THE PROCEDURE, THEY CHECKED IT TO DETERMINE IF IT WAS ALLOWING FLOW OF CEREBROSPINAL FLUID (CSF). AFTER PALPATING THE VALVE, THE CLINICIAN DECIDED THERE WAS NO CSF FLOW. THE VALVE WAS REPLACED. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7781362 ↗
• MalfunctionMay 4, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRE-OPERATIVE TESTING IT WAS FOUND THAT THERE WAS LEAK IN THE RESERVOIR. THE PRODUCT WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7488095 ↗
• MalfunctionNov 28, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT DURING SURGERY, THERE WAS POOR DRAINAGE WITH THE VALVE. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7063569 ↗
• MalfunctionNov 27, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PRE-OPERATIVE TESTING, IT WAS DETERMINED THAT THE DELTA CHAMBER WAS LEAKING. THE PRODUCT WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060984 ↗
• MalfunctionOct 26, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN TESTING THE VALVE INTRAOPERATIVELY, A LEAK WAS NOTICED. IT WAS STATED THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6982255 ↗
• MalfunctionAug 17, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHEN THE DOCTOR DID THE CEREBROSPINAL FLUID SHUNT SURGERY, DURING THE TEST BEFORE CATHETERIZATION, THEY FOUND THE VALVE ANTI-SIPHON LEAKED. ACCORDING TO THE REPORT, THE DEVICE WAS NEVER IMPLANTED, AND THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6800394 ↗
• MalfunctionJun 15, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE PROCEDURE, AFTER INSTALLING THE CATHETER AT BOTH ENDS, THE VALVE WAS FOUND TO BE LEAKING. ACCORDING TO THE REPORT, THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6644964 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K902783. One submission often covers many models, so check the product and lot details in each record.

• Z-1115-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 -
• Z-0871-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0872-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0873-2021 · Dec 16, 2020 · Open, Classified
  REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Contr
• Z-0398-2014 · Nov 18, 2013 · Terminated
  Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ve