Strata® 44420 (UDI 00643169010796)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169010796), received between Dec 1, 2016 and Jan 25, 2019 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K123524); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE VALVE HAD "POOR FLEXIBILITY." IT WAS STATED THAT WHEN THE VALVE WAS PRESSED DURING THE TEST, THE REBOUND SPEED WAS VERY SLOW. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE VALVE WAS EXPLANTED AND THE PATIENT¿S STATUS WAS LISTED AS ALIVE ¿ NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8279699 ↗
• InjuryJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE VALVE HAD ¿POOR FLEXIBILITY.¿ THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE VALVE WAS EXPLANTED AND THE PATIENT¿S STATUS WAS LISTED AS ALIVE ¿ NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227413 ↗
• InjuryMay 22, 2018Mechanics Altered; Appropriate Device Problem Term/Code Not Available; Migration; Mechanics Altered; Appropriate Device Problem Term/Code Not Available; Migration

  IT WAS REPORTED THE PATIENT NORMALLY WORE AN ALUMINUM PLATE TO SHIELD THEIR DEVICE FROM MAGNETIC INTERFERENCE; HOWEVER, WHILE AT THE MALL, THE STAFF INFORMED THEM THAT WEARING SUCH A DEVICE WOULD BE CONSTRUED AS A SHOPLIFTING ATTEMPT (CONCEALING MERCHANDISE SECURITY TAGS FROM THE MALL'S SENSORS), AND THEY ASKED THEM TO REMOVE IT. THE PATIENT ENTERED A FURNITURE SECTION WHERE PORTAL MAGNETIC TAG DETECTORS WHICH WERE CAREFULLY CONCEALED TO LOOK LIKE ADVERTISING DISPLAYS WERE USED AND DIDN'T SPOT THEM UNTIL THEY HAD ALREADY GONE THROUGH THEM. IT WAS NOTED THAT TO ENTER THE FURNITURE SECTION, THE CUSTOMER MUST FIRST TRANSIT THE ELECTRONICS DISPLAYS WHICH ARE LOADED WITH MAGNETICALLY CHARGED DEVICES. THEY WENT STRAIGHT THROUGH BECAUSE THEY WERE NOW STUCK IN THE STORE WITH NO SHIELDING FOR THEIR DEVICE, SO THEY EXITED THE STORE IMMEDIATELY. AN HOUR AFTER THE EVENT, THE PATIENT BEGAN FEELING UNWELL BUT DISMISSED IT AS EXHAUSTION FROM WALKING IN THE SUN. THE CONDITION WORSENED BY THE MORNING OF (B)(6)2018 WHERE THEY EXPERIENCED HEADACHE, LOSS OF BALANCE, AND MEMORY LOSS. BY (B)(6) 2018, THE CONDITION HAD WORSENED YET AGAIN TO INCLUDE HEADACHE (LEVEL 3 ON A 10-POINT SCALE), FEELING CONSTRIC

  Patient problems: Ambulation or Postural Difficulties; Confusion/ Disorientation; Headache; Memory Loss/Impairment; Pain

  MAUDE report 7534768 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT RECEIVED AN INFECTION ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 7532359 ↗
• MalfunctionFeb 28, 2018Mechanics Altered; Appropriate Device Problem Term/Code Not Available; Mechanics Altered; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT FELT THAT HER SETTINGS WERE CHANGING RANDOMLY ON THEIR OWN; THE SETTINGS CHANGED FROM 2.0 TO 0.5. THE PATIENT STATED THAT THEY WERE FEELING "DRY IN HER BRAIN, NECK, AND BRAIN STEM AS IF IT'S NOT FLOWING PROPERLY."

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7303704 ↗
• InjuryJan 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THERE WAS VALVE OBSTRUCTION AND IT COULD NOT BE SUCCESSFULLY DRAINED. THE VALVE WAS REPLACED AND THE PATIENT¿S STATUS WAS LISTED AS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7216978 ↗
• InjuryJan 24, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THE RESERVOIR¿S REBOUND RATE WAS SLOW DURING PRE-OPERATIVE TESTING. IT WAS STATED THE VALVE WAS NOT FLEXIBLE. THE VA LVE WAS IMPLANTED AND AFTER IMPLANT, THERE WAS REPORTEDLY ¿NO FUNCTION.¿ THE VALVE WAS REMOVED AND REPLACED. THE PATIENT¿S STATUS WAS LISTED AS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7215631 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PSEUDOTUMOR PATIENT WAS IMPLANTED IN (B)(6) 2016. ABOUT TWO WEEKS AFTER IMPLANT, THE PATIENT WAS DIZZY AND SICK. THEY WENT TO THE EMERGENCY ROOM WITH AN ELEVATED HEART RATE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH (B)(6). VANCOMYCIN WAS ADMINISTERED, AND THE SHUNT WAS EXPLANTED AT THE END OF (B)(6) 2016.

  Patient problems: Dizziness; Malaise; Staphylococcus Aureus; Tachycardia

  MAUDE report 7084687 ↗
• MalfunctionDec 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THE PATIENT WAS HAVING A LOT OF ISSUES WITH THEIR DEVICE AND WAS NOT FEELING WELL.

  Patient problems: Malaise

  MAUDE report 7075310 ↗
• InjuryOct 27, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THE VALVE WAS CLOGGED. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6983700 ↗
• MalfunctionOct 5, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN THE SURGEON DID THE PRE-SURGERY SHUNT TESTING, THE LUMBAR CATHETER WAS LEAKING. THE CATHETER WAS REPLACED AND THERE WAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915794 ↗
• MalfunctionSep 26, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE PHYSICIAN PRESSED THE VALVE AND ¿SUCTION SIDE,¿ THERE WAS ¿A LOT OF WATER SPRAY.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6894881 ↗
• MalfunctionJul 19, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE FLEXIBILITY OF THE VALVE WAS NOT GOOD DURING PRE-OPERATIVE TESTING. ACCORDING TO THE REPORT, WHEN THE SURGEON IMPLANTED THE VALVE AND TESTED AGAIN, IT WAS DETERMINED THE VALVE WAS NOT DRAINING. REPORTEDLY, THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6726355 ↗
• MalfunctionJul 14, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PERITONEAL CATHETER WAS LEAKING INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THE CATHETER WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6715515 ↗
• MalfunctionJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS NOT WORKING PRIOR TO IMPLANT DURING TESTING. ACCORDING TO THE REPORT, THE PREOPERATIVE OF THE VALVE BEFORE IMPLANTATION DIDN'T PASS. REPORTEDLY, THE VALVE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6712284 ↗
• MalfunctionJul 2, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE LUMBAR CATHETER WAS BROKEN PRIOR TO IMPLANT. ACCORDING TO THE REPORT, THE PRODUCT WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6683733 ↗
• MalfunctionMar 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE¿S RESERVOIR FLEXIBILITY WAS POOR INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THE DEVICE WAS NOT USED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6415645 ↗
• MalfunctionFeb 16, 2017Break; Break

  IT WAS REPORTED THE CATHETER RUPTURED INTRA-OPERATIVELY. ACCORDING TO THE REPORT, ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6335819 ↗
• InjuryDec 7, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS OBSTRUCTED AND COULD NOT DRAIN CEREBROSPINAL FLUID (CSF) AFTER IMPLANT. THE VALVE WAS REPLACED WITH ANOTHER VALVE TO SUCCESSFULLY DRAIN CSF AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6153613 ↗
• MalfunctionDec 6, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS OBSTRUCTED AND COULD NOT DRAIN CEREBROSPINAL FLUID (CSF) DURING THE PROCEDURE. ANOTHER VALVE WAS USED TO SUCCESSFULLY DRAIN CSF AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6149646 ↗
• MalfunctionDec 1, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE LUMBAR CATHETER WAS RUPTURED DURING THE PROCEDURE. IT WAS UNKNOWN IF A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6139704 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123524. One submission often covers many models, so check the product and lot details in each record.

• Z-1116-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHU