NA 43522Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169497122), received between Mar 1, 2019 and Dec 8, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K792005); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Break; Complete Blockage; Fracture; Insufficient Device Problem Information; Migration; Break; Complete Blockage; Fracture; Insufficient Device Problem Information; Migration

  DEL BIGIO, M.R., SIDHU, R.K., KAZINA, C.J., SERLETIS, D. INFLAMMATION AND OBSTRUCTION OF DISTAL CATHETER SLITS IN VENTRICULOPERITONEAL SHUNTS: LIKELY ROLE OF GRAPHITE. J NEUROSURG. 2020. 133 (1495¿1502) DOI: 10.3171/2019.6.JNS191082 OBJECTIVE TISSUE REACTIONS THAT CONTRIBUTE TO OBSTRUCTION OF PERITONEAL CATHETERS IN VENTRICULOPERITONEAL SHUNT SYSTEMS ARE NOT WELL CHARACTERIZED. SEVERAL RECENT RAPID OBSTRUCTIONS IN CHILDREN PROMPTED A RETROSPECTIVE QUALITY ASSURANCE REVIEW. METHODS THE AUTHORS CONDUCTED A DETAILED INVESTIGATION OF 22 SURGICALLY EXPLANTED PERITONEAL SHUNT CATHETERS AND 8 AUTOPSY CASES WITH DOCUMENTED DISTAL SHUNT OBSTRUCTION. PATIENTS¿ MEDICAL HISTORIES WERE REVIEWED, AND THE CATHETERS AND/OR TISSUES WERE SUBJECTED TO CONVENTIONAL HISTOLOGICAL AND IMMUNOHISTOCHEMICAL EVALUATIONS. IN ADDITION, 3 CASES WERE SUBJECTED TO ELECTRON MICROSCOPIC EXAMINATION INCLUDING ELEMENTAL ANALYSIS. RESULTS THE MAJORITY OF SYMPTOMATIC OBSTRUCTIONS WERE ASSOCIATED WITH DISTAL SLIT CATHETERS (17 SLIT, 3 OPEN-END, AND 2 UNKNOWN TYPE). AMONG THE AUTOPSY CASES, DEATHS WERE ATTRIBUTED TO SHUNT FAILURE IN 2 CASES OF SLIT CATHETER OBSTRUCTION, 1 CASE OF OPEN-END CATHETER OBSTRUCTION, AND 1 CASE

  Patient problems: Unspecified Infection

  MAUDE report 15944632 ↗
• MalfunctionDec 8, 2022Break; Complete Blockage; Fracture; Insufficient Device Problem Information; Migration; Break; Complete Blockage; Fracture; Insufficient Device Problem Information; Migration

  DEL BIGIO, M.R., SIDHU, R.K., KAZINA, C.J., SERLETIS, D. INFLAMMATION AND OBSTRUCTION OF DISTAL CATHETER SLITS IN VENTRICULOPERITONEAL SHUNTS: LIKELY ROLE OF GRAPHITE. J NEUROSURG. 2020. 133 (1495¿1502) DOI: 10.3171/2019.6.JNS191082 OBJECTIVE TISSUE REACTIONS THAT CONTRIBUTE TO OBSTRUCTION OF PERITONEAL CATHETERS IN VENTRICULOPERITONEAL SHUNT SYSTEMS ARE NOT WELL CHARACTERIZED. SEVERAL RECENT RAPID OBSTRUCTIONS IN CHILDREN PROMPTED A RETROSPECTIVE QUALITY ASSURANCE REVIEW. METHODS THE AUTHORS CONDUCTED A DETAILED INVESTIGATION OF 22 SURGICALLY EXPLANTED PERITONEAL SHUNT CATHETERS AND 8 AUTOPSY CASES WITH DOCUMENTED DISTAL SHUNT OBSTRUCTION. PATIENTS¿ MEDICAL HISTORIES WERE REVIEWED, AND THE CATHETERS AND/OR TISSUES WERE SUBJECTED TO CONVENTIONAL HISTOLOGICAL AND IMMUNOHISTOCHEMICAL EVALUATIONS. IN ADDITION, 3 CASES WERE SUBJECTED TO ELECTRON MICROSCOPIC EXAMINATION INCLUDING ELEMENTAL ANALYSIS. RESULTS THE MAJORITY OF SYMPTOMATIC OBSTRUCTIONS WERE ASSOCIATED WITH DISTAL SLIT CATHETERS (17 SLIT, 3 OPEN-END, AND 2 UNKNOWN TYPE). AMONG THE AUTOPSY CASES, DEATHS WERE ATTRIBUTED TO SHUNT FAILURE IN 2 CASES OF SLIT CATHETER OBSTRUCTION, 1 CASE OF OPEN-END CATHETER OBSTRUCTION, AND 1 CASE

  Patient problems: Unspecified Infection

  MAUDE report 15944270 ↗
• InjuryJan 24, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH HYDROCEPHALUS IN OR ABOUT (B)(6) 2018. AFTER GOING VARIOUS OPTIONS, THEIR MEDICAL TEAM RECOMMENDED SURGERY AND THE INSERTION OF A SHUNT TO DRAIN FLUID FROM THEIR HEAD. THE SURGERY TOOK PLACE THE MORNING OF (B)(6) 2019. THE PROCEDURE TOOK APPROXIMATELY 2 HOURS, DURING WHICH A VENTRICLE AND PERITONEAL CATHETER FROM THE MANUFACTURER WERE INSERTED IN ACCORDANCE WITH STANDARD PRACTICE AND PROCEDURE. WHILE IN POST-OP CARE THE SAME DAY AS THE SURGERY, THE PATIENT BECAME LETHARGIC AND LOST CONSCIOUSNESS. THEY WERE SUBSEQUENTLY TAKEN FOR A CT SCAN WHERE IT WAS DISCOVERED THAT THE SHUNT WAS DRAINING FLUID FAR TOO RAPIDLY. AS A RESULT, THEY WERE RUSHED INTO A FURTHER SURGERY WHERE THE SHUNT WAS CLAMPED OFF TO PREVENT FURTHER DRAINAGE, HOWEVER, THAT WAS NOT BEFORE THE PATIENT SUFFERED WHAT APPEARED TO BE SIGNIFICANT BRAIN DAMAGE INCLUDING, BUT NOT LIMITED TO, AN INABILITY TO WALK, PARALYSIS OF THEIR VOCAL CORDS, AN INABILITY TO EAT AMONG OTHER THINGS.

  Patient problems: Ambulation or Postural Difficulties; Dysphasia; Lethargy; Loss of consciousness; No Code Available

  MAUDE report 9628335 ↗
• MalfunctionMar 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PHYSICIAN SEEN RAPID OBSTRUCTIONS DUE TO GRAPHITE GRANULOMAS AT THE DISTAL ENDS OF THE PERITONEAL CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8383579 ↗
• MalfunctionMar 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PHYSICIAN SEEN RAPID OBSTRUCTIONS DUE TO GRAPHITE GRANULOMAS AT THE DISTAL ENDS OF THE PERITONEAL CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8383305 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K792005. One submission often covers many models, so check the product and lot details in each record.

• Z-0397-2014 · Nov 18, 2013 · Terminated
  CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Reg