Delta® 42833Recalls & reported problems
Medtronic Ps Medical, Inc. · VALVE 42833DELTA BURR HOLE 12MM LEV 1.5 · Class 2 · Implant
All models of Delta (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169466838), received between Mar 2, 2021 and Mar 2, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ETIOLOGY OF THE REOPERATION WAS THE SHUNT MALFUNCTION DUE TO EXTENSIVE INSERTION OF THE VENTRICULAR CATHETER INTO THE BRAIN PARENCHYMA. DURING THE INSPECTION OF THE CRANIAL FLAP, THERE WAS SWELLING UNDERNEATH. THE PHYSICIAN OPENED THE FLAP, AND THERE WAS CEREBROSPINAL FLUID AROUND THE VALVE MECHANISM. UNDER THE SURGICAL MICROSCOPE, IT WAS SEEN A SMALL RUPTURE AROUND THE VALVE MECHANISM, NOT IN THE RESERVOIR.
Patient problems: Swelling/ Edema
MAUDE report 11400060 ↗
Other Shunt, central nervous system and components devices
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- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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