NA 42542Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169466043), received between Mar 6, 2018 and Mar 4, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K841442); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DOCTOR WAS IN THE OPERATING ROOM FOR SHUNT INSTALLATION. THEY PREPARED THE VALVE, (FILLING THE VALVE WITH NORMAL SALINE PRESERVATIVE FREE) AND CONNECTED THE VALVE TO THE VENTRICULAR CATHETER. THE DOCTOR WATCHED THE CSF COMING OUT FROM THE DISTAL END OF THE VALVE AND THERE WAS NOTHING COMING BACK. THEY DISCONNECTED THE VALVE AND REFILLED THE VALVE AGAIN MAKING SURE THERE WAS NO AIR IN THE RESERVOIR. THEY RECONNECTED THE VALVE, AND THERE WAS NO CSF COMING OUT OF THE VALVE. THE DOCTOR TOOK ANOTHER VALVE AND IT DID THE SAME THING. THEY DECIDED TO USE A STRATA BURR HOLE VALVE, AND SET IT UP AT THE SAME LEVEL, AND THE CSF WAS FLOWING EASILY FORM THE DISTAL END OF THE VALVE. THE 2 VALVES WERE THROWN IN THE GARBAGE, AND THE 2 REMAINING VALVES ARE BEING RETRIEVED FROM THE HOSPITAL AND WILL BE RETURNED FOR ANALYSIS. THE PATIENT GOT A PROGRAMMABLE VALVE AND THEY WERE DOING FINE. IT WAS NOTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE NEUROSURGEON, AND THEY TESTED 1 OF THE 2 REMAINING VALVES WITH THE SAME SERIAL NUMBER, AND IT APPEARED THAT THE PROXIMAL END WAS NOT FLOWING. THE DOCTOR THINKS THAT THE PROXIMAL END WAS BLOCKED BECAUSE WHEN WHY WERE FILLING THE V

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789247 ↗
• MalfunctionMar 4, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DOCTOR WAS IN THE OR FOR SHUNT INSTALLATION. THEY PREPARED THE VALVE, (FILLING THE VALVE WITH NORMAL SALINE PRESERVATIVE FREE) AND CONNECTED THE VALVE TO THE VENTRICULAR CATHETER. THE DOCTOR WATCHED THE CSF COMING OUT FROM THE DISTAL END OF THE VALVE AND THERE WAS NOTHING COMING BACK. THEY DISCONNECTED THE VALVE AND REFILLED THE VALVE AGAIN MAKING SURE THERE WAS NO AIR IN THE RESERVOIR. THEY RECONNECTED THE VALVE, AND THERE WAS NO CSF COMING OUT OF THE VALVE. THE DOCTOR TOOK ANOTHER VALVE AND IT DID THE SAME THING. THEY DECIDED TO USE A STRATA BURR HOLE VALVE, AND SET IT UP AT THE SAME LEVEL, AND THE CSF WAS FLOWING EASILY FORM THE DISTAL END OF THE VALVE. THE 2 VALVES WERE THROWN IN THE GARBAGE, AND THE 2 REMAINING VALVES ARE BEING RETRIEVED FROM THE HOSPITAL AND WILL BE RETURNED FOR ANALYSIS. THE PATIENT GOT A PROGRAMMABLE VALVE AND THEY WERE DOING FINE. IT WAS NOTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE NEUROSURGEON, AND THEY TESTED 1 OF THE 2 REMAINING VALVES WITH THE SAME SERIAL NUMBER, AND IT APPEARED THAT THE PROXIMAL END WAS NOT FLOWING. THE DOCTOR THINKS THAT THE PROXIMAL END WAS BLOCKED BECAUSE WHEN WHY WERE FILLING THE VALVE WITH TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789243 ↗
• MalfunctionMar 4, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DOCTOR WAS IN THE OR FOR SHUNT INSTALLATION. THEY PREPARED THE VALVE, (FILLING THE VALVE WITH NORMAL SALINE PRESERVATIVE FREE) AND CONNECTED THE VALVE TO THE VENTRICULAR CATHETER. THE DOCTOR WATCHED THE CSF COMING OUT FROM THE DISTAL END OF THE VALVE AND THERE WAS NOTHING COMING BACK. THEY DISCONNECTED THE VALVE AND REFILLED THE VALVE AGAIN MAKING SURE THERE WAS NO AIR IN THE RESERVOIR. THEY RECONNECTED THE VALVE, AND THERE WAS NO CSF COMING OUT OF THE VALVE. THE DOCTOR TOOK ANOTHER VALVE AND IT DID THE SAME THING. THEY DECIDED TO USE A STRATA BURR HOLE VALVE, AND SET IT UP AT THE SAME LEVEL, AND THE CSF WAS FLOWING EASILY FORM THE DISTAL END OF THE VALVE. THE 2 VALVES WERE THROWN IN THE GARBAGE, AND THE 2 REMAINING VALVES ARE BEING RETRIEVED FROM THE HOSPITAL AND WILL BE RETURNED FOR ANALYSIS. THE PATIENT GOT A PROGRAMMABLE VALVE AND THEY WERE DOING FINE. IT WAS NOTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE NEUROSURGEON, AND THEY TESTED 1 OF THE 2 REMAINING VALVES WITH THE SAME SERIAL NUMBER, AND IT APPEARED THAT THE PROXIMAL END WAS NOT FLOWING. THE DOCTOR THINKS THAT THE PROXIMAL END WAS BLOCKED BECAUSE WHEN WHY WERE FILLING THE VALVE WITH TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789223 ↗
• MalfunctionMar 4, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DOCTOR WAS IN THE OPERATING ROOM FOR SHUNT INSTALLATION. THEY PREPARED THE VALVE, (FILLING THE VALVE WITH NORMAL SALINE PRESERVATIVE FREE) AND CONNECTED THE VALVE TO THE VENTRICULAR CATHETER. THE DOCTOR WATCHED THE CSF COMING OUT FROM THE DISTAL END OF THE VALVE AND THERE WAS NOTHING COMING BACK. THEY DISCONNECTED THE VALVE AND REFILLED THE VALVE AGAIN MAKING SURE THERE WAS NO AIR IN THE RESERVOIR. THEY RECONNECTED THE VALVE, AND THERE WAS NO CSF COMING OUT OF THE VALVE. THE DOCTOR TOOK ANOTHER VALVE AND IT DID THE SAME THING. THEY DECIDED TO USE A STRATA BURR HOLE VALVE, AND SET IT UP AT THE SAME LEVEL, AND THE CSF WAS FLOWING EASILY FORM THE DISTAL END OF THE VALVE. THE 2 VALVES WERE THROWN IN THE GARBAGE, AND THE 2 REMAINING VALVES ARE BEING RETRIEVED FROM THE HOSPITAL AND WILL BE RETURNED FOR ANALYSIS. THE PATIENT GOT A PROGRAMMABLE VALVE AND THEY WERE DOING FINE. IT WAS NOTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE NEUROSURGEON, AND THEY TESTED 1 OF THE 2 REMAINING VALVES WITH THE SAME SERIAL NUMBER, AND IT APPEARED THAT THE PROXIMAL END WAS NOT FLOWING. THE DOCTOR THINKS THAT THE PROXIMAL END WAS BLOCKED BECAUSE WHEN WHY WERE FILLING THE V

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9788789 ↗
• MalfunctionJun 12, 2019Break; Fracture; Appropriate Device Problem Term/Code Not Available; Break; Fracture; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING CSF MANAGEMENT SURGERY. IT WAS REPORTED THAT WHEN PRE-TESTING TO VENT THE PRODUCT, THE DEVICE WAS UNABLE TO ABSORB WATER, THE WHOLE DEVICE FLATTENED, AND IT COULD NOT BE EXHAUSTED. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8691855 ↗
• InjuryMar 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE VALVE HAD POOR ELASTICITY AND WAS UNABLE TO REBOUND. THE VALVE WAS EXPLANTED ON (B)(6) 2018. THERE WERE NO SYMPTOMS REPORTED AND THE PATIENT'S STATUS WAS LISTED AS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316186 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K841442. One submission often covers many models, so check the product and lot details in each record.

• 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-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