BioGlide® 93522 (UDI 00643169466005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169466005), received between Dec 7, 2016 and Apr 5, 2023 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

31 other recalls cover devices cleared under the same FDA submission (K951258); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2023Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. AFTER THE PATIENT'S POSTOPERATIVE EXAMINATION, IT WAS FOUND THAT THE SHUNT SYSTEM WAS BLOCKED. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION AND FOUND THAT 93522 WAS WRAPPED BY TISSUE, AND THE DOCTOR REPLACED WITH A CATHETER OF THE SAME TYPE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16685856 ↗
• MalfunctionMar 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING DURING IMPLANT, SO IT WAS REPLACED. THE PATIENT STATUS IS ALIVE ¿ NO INJURIES. THE PROCEDURE TIME WAS EXTENDED BY 1 MINUTE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440628 ↗
• InjuryOct 20, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE SHUNT SYSTEM WAS NOT SMOOTH, AND THE VALVE WAS BLOCKED. THE SHUNT SYSTEM AND VALVE WAS REPLACED WITH A NEW ONE. THE PATIENT'S MEDICAL HISTORY WAS HYDROCEPHALUS.

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

  MAUDE report 10708348 ↗
• InjuryJul 1, 2020Infusion or Flow Problem; Infusion or Flow Problem

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

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10217773 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A VENTRICULOPERITONEAL SHUNT. THE PATIENT DEVELOPED A FEVER 3 DAYS AFTER THE SURGERY AND WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS BUT FAILED TO ACHIEVE THE EXPECTED EFFECT. IT WAS THOUGHT THAT THERE MIGHT BE A SHUNT INFECTION. THE SHUNT WAS EXPLANTED, AND THE CORRESPONDING TREATMENT MEASURES WOULD BE TAKEN ACCORDING TO THE SPECIFIC SITUATION OF THE PATIENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE - WITH INJURY.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 9800058 ↗
• InjuryDec 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PERITONEAL CATHETER WAS EXPLANTED AS PART OF A SHUNT REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9439134 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING CEREBRAL PERITONEAL SHUNT SURGERY DUE TO TRAUMATIC BRAIN INJURY. IT WAS REPORTED THAT THE PATIENT HAD A CONTINUOUS FEVER THAT OCCURRED ONE WEEK AFTER SURGERY AND DID NOT IMPROVE. AS THERE WAS A RISK OF INFECTION, THE DEVICE WAS REMOVED. AFTER THE PATIENT RETURNED TO NORMAL ANOTHER SURGERY WAS COMPLETED. THERE WAS NO PRODUCT DAMAGE. THERE WERE NO RELATED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ADJUSTMENT WAS DONE ANYTIME AFTER IMPLANTATION. NO ACTIVITIES/ANALYSES WERE DONE ON THE VALVE AFTER THE REMOVAL FROM THE PATIENT PRIOR TO SENDING IT TO THE MANUFACTURER. THE VALVE WAS NOT BATHED IN ANY CHEMICALS OR ANTIBIOTICS PRIOR TO IMPLANTATION. NO MRI'S WERE PERFORMED WHILE THE DEVICE WAS IMPLANTED.

  Patient problems: Fever

  MAUDE report 8562480 ↗
• MalfunctionDec 7, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD SURGERY ON (B)(6) 2016 DUE TO HYDROCEPHALUS. ACCORDING TO THE REPORT ON (B)(6) 2016, THE PATIENT HAD ABDOMINAL SURGERY AND WHEN SUTURING THE PERITONEUM THE DEVICE WAS FOUND TO BE BROKEN INTO THREE PIECES. THE REPORT STATED THAT TWO PIECES WERE RETRIEVED FROM THE PATIENT'S BODY AND ONE PIECE REMAINS IN THE PATIENT'S BODY FOR DRAINAGE. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT AND THEY WERE DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6153634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951258. 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-1117-2021 · Jan 11, 2021 · Open, Classified
  Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY
• Z-1142-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1126-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Sizes: 4.5 CM in length, REF (240) 27782J. Each catheter is provided in a sealed Tyvek pl
• Z-1125-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes:5.5CM in length, REF (240) 27782K. Each catheter is provided in a sealed Tyvek plas
• Z-1149-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
• Z-1135-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1136-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1132-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plas
• Z-1127-2009 · Feb 12, 2009 · Terminated
  Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H. Sizes: 11 CM in length, REF (240) 27782H. Each catheter is provided in a sealed Tyvek pla
• Z-1141-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The s
• Z-1140-2009 · Feb 12, 2009 · Terminated
  Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
• Z-1145-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
• Z-1151-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar p
• Z-1146-2009 · Feb 12, 2009 · Terminated
  Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po

…and 16 more.