DeltaRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 0
We found 31 models of Delta by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Sep 11, 2026 — classified as 29 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Delta problems
Device problems
- Device Misassembled During Manufacturing /Shipping20
- Break16
- Fluid/Blood Leak15
- Infusion or Flow Problem13
- Appropriate Device Problem Term/Code Not Available12
- Insufficient Device Problem Information11
- Complete Blockage8
- Leak/Splash7
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- No Known Impact Or Consequence To Patient41
- Headache4
- Apnea3
- Convulsion/Seizure3
- Hydrocephalus3
- Insufficient Information3
- Therapeutic Response, Decreased3
Delta models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Delta® 27219-1Shunt, central nervous system and components24 reports
- Delta® 25132-5Shunt, central nervous system and components17 reports
- Delta® 25131-5Shunt, central nervous system and components9 reports
- Delta® 27219-5Shunt, central nervous system and components7 reports
- Delta® 27219-5Shunt, central nervous system and components6 reports
- Delta® 25132-5Shunt, central nervous system and components6 reports
- Delta® 42813Shunt, central nervous system and components5 reports
- Delta® 25132-5Shunt, central nervous system and components3 reports
- Delta® 25131-5Shunt, central nervous system and components3 reports
- Delta® 42823Shunt, central nervous system and components3 reports
- Delta® 42822Shunt, central nervous system and components2 reports
- Delta® 42813Shunt, central nervous system and components2 reports
- Delta® 42812Shunt, central nervous system and components2 reports
- Delta® 25132-1Shunt, central nervous system and components2 reports
- Delta® 25131-2Shunt, central nervous system and components2 reports
- Delta® 42812Shunt, central nervous system and components2 reports
- Delta® 24053Shunt, central nervous system and components1 report
- Delta® 25014-5Shunt, central nervous system and components1 report
- Delta® 42812Shunt, central nervous system and components1 report
- Delta® 24053Shunt, central nervous system and components1 report
- Delta® 42833Shunt, central nervous system and components1 report
- Delta® 42832Shunt, central nervous system and components1 report
- Delta® 46813Shunt, central nervous system and components1 report
- Delta® 25014-5Shunt, central nervous system and components1 report
- Delta® 27554-5Shunt, central nervous system and components1 report
- Delta® 42843Shunt, central nervous system and components1 report
- Delta® 24027-1Shunt, central nervous system and components1 report
- Delta® 27219-1Shunt, central nervous system and components1 report
- Delta® 24053Shunt, central nervous system and components1 report
- Delta® 42823Shunt, central nervous system and components1 report
- Delta® 46832Shunt, central nervous system and components1 report
Recent Delta adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Fluid/Blood Leak
Medtronic received information regarding a valve. It was reported that the valve was tested before surgery, however, valve leakage occurred. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733775 ↗MalfunctionMay 15, 2026Complete Blockage
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR WAS CONFUSED, AND THE FAULTY PRODUCT WAS NOT A MEDTRONIC PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25182622 ↗InjuryApr 8, 2026Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THE SHUNT BECAME DISCONNECTED FROM THE RESERVOIR TO THE PERITONEAL CATHETER. THE DOCTOR WENT IN ON (B)(6) 2026 AND RECONNECTED IT. ON (B)(6) 2026, THE DOCTORS FOUND THAT THE SAME SHUNT WAS AGAIN DISCONNECTED AND INFECTED.
Patient problems: Unspecified Infection
MAUDE report 24820955 ↗MalfunctionJan 22, 2026Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS OCCLUDED AT THE TIME OF VALVE OCCLUSION TESTING. WHEN INJECTING TO CHECK WHETHER THE VALVE SYSTEM WAS PATENT, THE PHYSICIAN FOUND THAT INJECTION WAS VERY DIFFICULT. WHEN THE CATHETER WAS CONNECTED, NO FLUID FLOWED DESPITE VERY HIGH PRESSURE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24147974 ↗MalfunctionJan 16, 2026Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THE VALVE WAS OBSTRUCTED AT THE TIME OF THE PATENCY TEST. WHEN INJECTING TO CHECK WHETHER THE VALVE SYSTEM WAS PATENT, THE PHYSICIAN NOTED VERY HIGH RESISTANCE. WHEN CONNECTED TO THE CATHETER, NO FLUID FLOWED DESPITE VERY HIGH PRESSURE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092493 ↗MalfunctionDec 22, 2025Complete Blockage; Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS OCCLUDED AT THE TIME OF OCCLUSION TESTING. WHEN INJECTING TO CHECK WHETHER THE VALVE SYSTEM WAS PATENT, THE PHYSICIAN FELT SIGNIFICANT RESISTANCE DURING INJECTION. AFTER CONNECTING THE CATHETER, NO FLUID FLOWED DESPITE VERY HIGH PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862667 ↗InjuryDec 10, 2025Infusion or Flow Problem; Infusion or Flow Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS IMPLANTED ON (B)(6) 2025. THE PATIENT WENT BACK IN FOR A REVISION SURGERY ON (B)(6) 2025. THE SURGEON STATED THAT THE VALVE WAS DEFECTIVE AND NOT PROPERLY FLOWING. THE SURGERY REPLACED ALL COMPONENTS OF THE SHUNT SYSTEM WITH NEW PARTS. NO ADVERSE EVENTS WITH THE PATIENT HAVE BEEN REPORTED FROM THE SURGEON/FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766965 ↗MalfunctionOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THERE WAS A LEAK HOLE WHEN TESTING THE VALVE BEFORE THE OPERATION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321743 ↗InjurySep 4, 2025Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT AFTER SURGERY, THE ABDOMINAL END TUBE WAS FOUND TO BE FALLEN OFF. THE TUBE WAS REPLACED WITH A NEW ONE. THERE WAS A PROCEDURE DELAY OF 30 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963053 ↗InjurySep 3, 2025Complete Blockage; Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT DESPITE THE PRESENCE OF PRESSURED CEREBROSPINAL FLUID (CSF), WHEN THE PROXIMAL SIDE OF THE SHUNT WAS IMPLANTED IN THE PATIENT, NO CSF FLOW WAS OBSERVED FROM THE DISTAL END WHEN THE PUMP AND DISTAL END WERE CONNECTED. EVEN WHEN THE TIP WAS LOWERED BELOW THE VENTRICLE LEVEL, NO CSF FLOW WAS OBSERVED DESPITE THE FLOW OF CSF BY PUMPING. THE PATIENT WAS PLACED ON DRAINAGE AND AN ADJUSTABLE SHUNT WAS IMPLANTED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DEVELOPED HYDROCEPHALUS BECAUSE THE SHUNT DID NOT FUNCTION AFTER THE PROCEDURE. THE PATIENT EXPERIENCED EPILEPTIC SEIZURES AND SPONTANEOUS RESPIRATORY LOSS AND WERE CONNECTED TO MECHANICAL VENTILATORS, THAT IN PATIENT UNDERGOING REVISION, AN EVD HAD TO BE INSERTED, ON GROUNDS THE SHUNT WAS SEEN TO BE FUNCTIONING BY PUMPING.
Patient problems: Apnea; Convulsion/Seizure; Hydrocephalus
MAUDE report 22955589 ↗InjuryAug 22, 2025Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT AFTER THE VALVE IMPLANTATION IN (B)(6), THE PATIENT DID NOT IMPROVE AS THE VALVE WAS NOT FUNCTIONAL. ANOTHER EMERGENCY PROCEDURE WAS PERFORMED TO REPLACE THE VALVE WITH AN ADJUSTABLE VALVE.
Patient problems: Dizziness; Headache; Insufficient Information; Intracranial Hemorrhage
MAUDE report 22878082 ↗InjuryAug 19, 2025Complete Blockage; Complete Blockage
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DEVELOPED HYDROCEPHALUS BECAUSE THE SHUNT DID NOT FUNCTION AFTER THE PROCEDURE. THE PATIENT EXPERIENCED EPILEPTIC SEIZURES AND SPONTANEOUS RESPIRATORY LOSS AND WERE CONNECTED TO MECHANICAL VENTILATORS, THAT IN PATIENT UNDERGOING REVISION, AN EVD HAD TO BE INSERTED, ON GROUNDS THE SHUNT WAS SEEN TO BE FUNCTIONING BY PUMPING.
Patient problems: Apnea; Convulsion/Seizure; Hydrocephalus; No Clinical Signs, Symptoms or Conditions
MAUDE report 22839506 ↗InjuryAug 19, 2025Complete Blockage; Complete Blockage
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DEVELOPED HYDROCEPHALUS BECAUSE THE SHUNT DID NOT FUNCTION AFTER THE PROCEDURE. THE PATIENT EXPERIENCED EPILEPTIC SEIZURES AND SPONTANEOUS RESPIRATORY LOSS AND WAS CONNECTED TO MECHANICAL VENTILATORS, THAT IN PATIENT UNDERGOING REVISION, AN EVD HAD TO BE INSERTED, ON GROUNDS THE SHUNT WAS SEEN TO BE FUNCTIONING BY PUMPING.
Patient problems: Apnea; Convulsion/Seizure; Hydrocephalus; No Clinical Signs, Symptoms or Conditions
MAUDE report 22839498 ↗InjuryMar 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT THE VALVE WAS PLACED ON (B)(6) 2025, AND THE PATIENT CAME BACK TO THE OPERATING ROOM ON (B)(6) 2025, TO HAVE A SHUNT REVISION AS THE VALVE WAS NOT WORKING. ALL OTHER COMPONENTS OF THE SHUNT WERE WORKING APPROPRIATELY. THE SHUNT WAS ALSO LOCATED IN THE APPROPRIATE POSITIONING FOR DRAINAGE WHICH WAS CHECKED DURING THE PROCEDURE ON (B)(6) 2025. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21618282 ↗MalfunctionJan 28, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED DURING THE SHUNT PLACEMENT OPERATION, A HOLE WAS DETECTED IN THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252026 ↗
Other Medtronic Ps Medical, Inc. products
All Medtronic Ps Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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