TRUWAVE, VAMP T005048BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07460691949270), received between Nov 13, 2024 and Nov 13, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 other recalls 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING USE IN PATIENT OF THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP, THE PRESSURE TUBING BETWEEN THE DPT HOUSING AND VAMP DETACHED FROM THE VAMP SIDE. THERE WAS 3-5ML OF BLOOD LOSS. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20671367 ↗

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),
• Z-0414-2024 · Oct 4, 2023 · Open, Classified
  TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm)