Strata® 44421 (UDI 00643169010789)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169010789), received between Jun 7, 2017 and Jul 10, 2018 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2018Break; Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHEN THE LUMBAR CATHETER WAS LIGATED TO ADDRESS OVERDRAINAGE OF CEREBROSPINAL FLUID (CSF), THE LUMBAR CATHETER TORE. IT WAS STATED THE LUMBAR CATHETER AND VALVE WERE REPLACED.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 7673931 ↗
• MalfunctionMar 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PREPARATION FOR THE PROCEDURE, VALVE PRIMING WAS PERFORMED, HOWEVER, THE AMOUNT OF SOLUTION DISCHARGE WAS NOT UNIFORM DURING FLUSHING. THE DEVICE WAS NOT USED AND REPLACED WITH ANOTHER ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339246 ↗
• MalfunctionNov 29, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AFTER THE BACKUP WAS UNPACKED, THEY COULD NOT ACHIEVE A PERFORMANCE LEVEL 2.0 BY AN ADJUSTMENT TOOL, AND THE TOOL POINTED AT THE WHITE BELT BETWEEN THE PERFORMANCE LEVEL 2.5 AND 2.0. NONETHELESS, THE PROCEDURE WAS COMPLETED PER THE PHYSICIAN'S DECISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068943 ↗
• InjuryNov 27, 2017Occlusion Within Device; Occlusion Within Device

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE INFECTIONS WAS UNKNOWN, HOWEVER IT WAS NOTED THE INFECTIONS WERE NOT RELATED TO THE DEVICE. THE PATIENT UNDERWENT AN IMPLANT OF A VENTRICULOPERITONEAL SHUNT IN LATE (B)(6) 2018. THE PATIENT¿S STATUS WAS GOOD.

  Patient problems: Bacterial Infection; Hepatitis; No Known Impact Or Consequence To Patient

  MAUDE report 7060638 ↗
• MalfunctionNov 3, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO CHANGE PRESET PRESSURE BUT FAILED. A BACK-UP LUMBAR PERITONEAL VALVE WAS USED TO SET UP PRESSURE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE MANUFACTURER'S REPRESENTATIVE (REP) RECEIVED THE PRODUCT AND ATTEMPTED TO ADJUST THE SETTING, AND THEY COULD ADJUST IT. THE SETTING WAS AT PERFORMANCE LEVEL 2.5. THE REP THOUGHT PERSONALLY THAT THE DOCTOR TRIED TO ADJUST BY ROTATING CLOCKWISE, AND THE SETTING WAS COMING AND GOING BETWEEN PERFORMANCE LEVEL 2.0 AND 2.5 SO THEN THE DOCTOR MIGHT HAVE THOUGHT THAT THE SETTING WAS UNAVAILABLE TO BE CHANGED BECAUSE THE INITIAL SETTING WAS USUALLY PERFORMANCE LEVEL 0.5. THE DOCTOR REPORTED THAT THE SETTING PRESSURE WAS UNAVAILABLE TO BE ADJUSTED AT FIRST, HOWEVER, THE REP CONFIRMED THE DETAILS. THEY HEARD THAT THE SETTING WOULD BE SET BETWEEN PERFORMANCE LEVEL 2.0 AND 2.5, AND THE DOCTOR UNDERSTOOD THE SETTING. IT WAS NOTED THAT THE PERFORMANCE LEVEL WAS ABLE TO BE SET WITHIN THE BLUE RANGE EXCEPT 2.0. ONLY 2.0 WAS NOT ABLE TO BE SET WITHIN THE BLUE RANGE, BUT 2.0 WAS ABLE TO BE SET WITHIN THE WHITE RANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7000811 ↗
• MalfunctionSep 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER WAS NOT INSERTED NORMALLY IN THE INSERTION NEEDLE IN THE VERTEBRAE LUMBALES. ACCORDING TO THE REPORT, RESISTANCE WAS ENCOUNTERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6867393 ↗
• MalfunctionAug 11, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PRIMING WAS UNABLE TO BE PERFORMED. ACCORDING THE REPORT, THE DEVICE WAS NEVER IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6789447 ↗
• InjuryJun 7, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT CEREBROSPINAL FLUID DID NOT FLOW NORMALLY EVEN THEN THE PRESSURE LEVEL WAS 0.5. ACCORDING TO THE REPORT, IT WAS SUSPECTED THERE WAS A MALFUNCTION WITHIN THE VALVE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER¿S DEVICE AND A PARTIAL EXPLANT WAS NOTED. REPORTEDLY, THERE WAS NO PATIENT IMPACT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6620906 ↗

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