TRUWAVE X 2 (3 CC) /VAMP 88 IN (225 CM) T434501BRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

1 other recall cover devices cleared under the same FDA submission (K183413); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 4, 2023Class IIOpen, Classified

   Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

   Z-0414-2024 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183413. One submission often covers many models, so check the product and lot details in each record.

• Z-0413-2024 · Oct 4, 2023 · Open, Classified
  TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc),