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Exacta™ 27732Recalls & reported problems

Medtronic Ps Medical, Inc. · EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000333560), received between Apr 21, 2021 and Apr 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Nov 1, 2024Open, Classified

    Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

    Z-0662-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Break1
  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 21, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

    ADDITIONAL INFORMATION RECEIVED THERE WERE NO EXTERNAL/ENVIRONMENTAL/PATIENT FACTORS THAT CONTRIBUTED TO THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11701571 ↗

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.