PROGAV 2.0 FX643TRecalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 04041906502010), received between Oct 23, 2020 and Sep 14, 2026 — classified as 98 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (85 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 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Infusion or Flow Problem; Physical Resistance/Sticking

  It was reported that a proGAV 2.0 Shuntsystem (#FX643T) was implanted on (b)(6) 2021.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2026.

  Patient problems: Hydrocephalus

  MAUDE report 50751988 ↗
• InjuryJul 27, 2026Obstruction of Flow

  It was reported that a proGAV 2.0 shunt system(#FX643T) was implanted on (b)(6) 2026. According to the complainant, the shunt system caused an under-drainage. The patient underwent a revision procedure on (b)(6) 2026. No patient complications were reported as a result of the revision procedure.

  Patient problems: Hydrocephalus

  MAUDE report 50038897 ↗
• InjuryJun 15, 2026Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643X) WAS IMPLANTED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.

  Patient problems: Hydrocephalus

  MAUDE report 25505592 ↗
• InjuryMay 4, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX597T) WAS IMPLANTED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 25070598 ↗
• InjuryApr 27, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643T) WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDER-DRAINAGE AND WAS EXPLANTED ON THE SAME DAY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS # 3004721439-2026-00112.

  Patient problems: Hydrocephalus

  MAUDE report 25002300 ↗
• InjuryApr 27, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS OCCLUDED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS #: 3004721439-2026-00113.

  Patient problems: Hydrocephalus

  MAUDE report 25002195 ↗
• InjuryApr 20, 2026Infusion or Flow Problem

  IT WAS REPORTED THA A PROGAV 2.0 WITH A SHUNTASSISTANT 2.0 (25) (#FX643T) WERE IMPLANTED DURING A PROCEDURE PERFORMED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 24927996 ↗
• InjuryApr 13, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYTSEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 24860054 ↗
• InjuryApr 7, 2026Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 24802356 ↗
• InjuryFeb 23, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 24413708 ↗
• InjuryOct 20, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX577T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. SAME EVENT AS MED WATCH NO.: 3004721439-2025-00255.

  Patient problems: Hydrocephalus

  MAUDE report 23335268 ↗
• InjuryOct 15, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025 NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 23277797 ↗
• InjuryJul 21, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 22554383 ↗
• InjuryMar 17, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX643T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 21618100 ↗
• InjuryMar 10, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21558762 ↗
• InjuryFeb 24, 2025Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 21447863 ↗
• InjuryJan 31, 2025Obstruction of Flow; Physical Resistance/Sticking; Obstruction of Flow; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21283946 ↗
• InjuryJan 27, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PROGAV 2.0 (#FX643T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hydrocephalus

  MAUDE report 21242530 ↗
• InjuryJan 15, 2025Obstruction of Flow; Obstruction of Flow

  THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 21158219 ↗
• MalfunctionJan 13, 2025Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 (FX643T) WAS NOT ADJUSTABLE BEFORE USE. THE PRODUCT IS STILL IN THE STERILE PACKAGING AND HAS NOT BEEN USED. THE COMPLAINED PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Hydrocephalus

  MAUDE report 21137016 ↗
• InjuryDec 27, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN PROGAV 2.0 SHUNT SYSTEM( # FX643T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINED PRODUCT WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 21026861 ↗
• InjuryDec 9, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE SYSTEM WAS NOT IMPLANTED PARALLEL TO THE BODY AXIS (SEE QUESTIONNAIRE) AND SCHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION IN THE PROVIDED RETURNKIT, SUBMERGED IN LIQUID. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 20877661 ↗
• InjuryNov 25, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX643T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 20774911 ↗
• InjuryNov 13, 2024Infusion or Flow Problem; Physical Resistance/Sticking; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX643T) WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 20673640 ↗
• InjurySep 30, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX643T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM SHOWED AN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2024. THE COMPLAINANT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 3 YEARS, 6 MONTHS. WEIGHT: 16 KGS. HEIGHT: 105 CM. GENDER: FEMALE.

  Patient problems: Hydrocephalus

  MAUDE report 20333572 ↗