Strata® 44421 (UDI 00763000027520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000027520), received between Mar 26, 2025 and Sep 11, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Mechanics Altered

  Medtronic received information regarding an adjustable valve. It was reported that the patient was diagnosed with idiopathic intracranial hypertension after failure of conservative management. Following a detailed discussion of the available treatment options with the patient and their family, the decision was made to proceed with placement of a lumboperitoneal (LP) shunt. Prior to surgery, the valve was programmed to a setting of 1.5.The procedure was performed on (b)(6) 2025, and was uneventful. Following surgery, the patient experienced gradual and significant improvement in her symptoms. Approximately one month postoperatively, however, the patient reported recurrence of her symptoms, including headaches, nausea and blurred vision. Appropriate investigations were performed to assess the position of the shunt, which demonstrated that the shunt was appropriately positioned without evidence of malposition. The valve setting was subsequently checked and was found to have changed from the original setting of 1.5 to 1.0. The valve was reprogrammed to 1.5, following which the patient's symptoms again improved. Of note, during this period, the patient had not undergone MRI examination

  Patient problems: Blurred Vision; Headache; Nausea

  MAUDE report 50732520 ↗
• MalfunctionJan 29, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT ON (B)(6) 2025, THE DOCTOR DISCOVERED CATHETER DAMAGE DURING A LUMBOSACRAL PERITONEAL SHUNT PROCEDURE USING THE REPORTED DEVICE IN THE OPERATING ROOM. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A PRODUCT OF THE SAME MODEL. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208898 ↗
• MalfunctionOct 28, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT ON THE OPERATING TABLE, AFTER OPENING THE PACKAGE, THE SURGEON ROUTINELY CHECKED THE VALVE AND CATHETER PATENCY AND FOUND THAT THE LUMBAR SEGMENT TUBE WAS DAMAGED. THE DEVICE WAS REPLACED WITH A NEW ONE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402985 ↗
• MalfunctionSep 11, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2025, UNDER GENERAL ANESTHESIA, THE PATIENT UNDERWENT LUMBAR CISTERN-ABDOMINAL SHUNT SURGERY. POSTOPERATIVELY, THE SHUNT VALVE PRESSURE WAS ADJUSTED MULTIPLE TIMES (ON (B)(6) 2025, TO SETTING 2.0, ON (B)(6) 2025, TO SETTING 1.5, AND ON (B)(6) 2025, TO SETTING 1.0). ON (B)(6) 2025, DUE TO RIGHT CHRONIC SUPPURATIVE OTITIS MEDIA WITH CHOLESTEATOMA, THE PATIENT UNDERWENT RIGHT OPEN MODIFIED RADICAL MASTOIDECTOMY, AND POSTOPERATIVE RECOVERY WAS GOOD. ON (B)(6) 2025, PHYSICAL EXAMINATION REVEALED SUBCUTANEOUS FLUID ACCUMULATION AT THE SHUNT RESERVOIR IN THE RIGHT HIP. AN URGENT SUPERFICIAL COLOR DOPPLER ULTRASOUND SHOWED AN ANECHOIC FLUID AREA SURROUNDING THE SHUNT TUBE. ON (B)(6) 2025, APPROXIMATELY 10 ML OF FLUID (LIGHT RED, ODORLESS) WAS ASPIRATED BY PUNCTURE, AND THE SHUNT VALVE PRESSURE WAS FURTHER ADJUSTED TO SETTING 1.0. ON (B)(6) 2025, PHYSICAL EXAMINATION SHOWED THAT THE SENSATION OF FLUID ACCUMULATION WAS REDUCED COMPARED TO BEFORE, WITH NO REDNESS OR TENDERNESS. TO EVALUATE SHUNT FUNCTION, AN URGENT UPRIGHT ABDOMINAL X-RAY WAS PERFORMED, WHICH INDICATED "DISCONTINUITY AT THE SHUNT VALV

  Patient problems: Seroma

  MAUDE report 23025512 ↗
• InjuryMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT DURING HOSPITALIZATION FOLLOWING THE LUMBOPERITONEAL SURGERY, A SUSPECTED LEAK WAS DETECTED IN THE SHUNT. UPON SURGICAL EXPLORATION, THE VALVE WAS FOUND TO BE LEAKING. THE VALVE WAS REPLACED DURING THE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017625 ↗
• MalfunctionMar 26, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2025, IN THE OPERATING ROOM, THE DOCTOR PERFORMED A LUMBAR SACRAL PERITONEAL SHUNT. DURING THE OPERATION, THE CATHETER WAS FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699179 ↗

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