GoFlo Pump A127Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056702003715), received between May 28, 2018 and Jun 17, 2018 — classified as 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K062380); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2018Calibration Problem

  IT WAS REPORTED CALIBRATION ISSUES HAVE CAUSED HIGH FLOW. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7608474 ↗
• MalfunctionMay 30, 2018Pressure Problem

  IT WAS REPORTED THAT DURING SURGERY, THE WATER PRESSURE OF THE PUMP RISE RAPIDLY AND THE PUMP TURNED QUICKLY, SO THE WATER WAS LOWERED TO 5, BUT THE PUMP CONSTANTLY TURNED QUICKLY AND INTERRUPTED THE OP. OBSTRUCTION OF VISION. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7553443 ↗
• MalfunctionMay 28, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A HALFWAY INTO CASE THE SURGEON NOTICED THAT THE PATIENTS OPERATIVE SHOULDER WAS BEGINNING TO SWELL DUE TO EXTRAVASATION. HE REQUESTED TO HIS ASSISTANT TO REDUCE THE PRESSURE ( WAS RUNNING ON 40MMHG), ASSISTANT REDUCED THE PRESSURE TO 30MMHG. EXTRAVASATION CONTINUED RAPIDLY, SURGEON REMOVED THE TROCAR AND CANNULA FROM THE PATIENT WITH FLUID STILL RUNNING, FLUID FLOW WAS EXTREMELY FAST OUT OF TROCAR AT 300MMHG. THE SURGEON REQUESTED THE PUMP TO BE STOPPED AND RETURNED TO THE HOSPITALS TYPICAL FLUID PUMP SYSTEM ( LINVATEC 10K).

  Patient problems: Swelling

  MAUDE report 7547394 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062380. One submission often covers many models, so check the product and lot details in each record.

• Z-2243-2024 · May 24, 2024 · Open, Classified
  WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-0