FloPump FloPump/FloProbe Kit (Sterile)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814321020094), received between Feb 4, 2016 and Nov 22, 2017 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Pumping Problem” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IN THE FILL AND CIRCULATION OF THE PRIMING SOLUTION IT WAS OBSERVED AIR/ BUBBLES IN THE CENTRIFUGAL PUMP. STOPPED THE CIRCULATION, AND THE PERFUSIONIST SAW AIR ENTRANCE IN THE SIDE OF THE PRODUCT, WITHOUT LEAKING LIQUID. EXCHANGED FOR A NEW PRODUCT, CIRCULATED THE PRIME WITHOUT PROBLEMS. THERE WAS NO INJURY FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052714 ↗
• MalfunctionNov 22, 2017Crack; Leak/Splash; Crack

  CUSTOMER OBSERVED NACL SOLUTION BETWEEN THE AXIS AND THE PLASTIC BASE. (NO CONTACT WITH THE PATIENT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7052712 ↗
• MalfunctionJul 12, 2017Pumping Problem; Pumping Problem

  CUSTOMER REPORTED THAT WHEN FILLING THE PRIMING CIRCUIT WITH PHYSIOLOGICAL SALINE SOLUTION, VERIFIED A CRACKING IN SURFACE OF THE PRODUCT. (NO CONTACT WITH THE PATIENT).

  Patient problems: No Patient Involvement

  MAUDE report 6705729 ↗
• MalfunctionJun 27, 2017Fluid/Blood Leak; Fluid/Blood Leak; Device Operates Differently Than Expected

  CUSTOMER OBSERVED THE SALINE SOLUTION HAVING CONTACT WITH THE MAGNET BEFORE USE. (NO CONTACT WITH THE PATIENT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6670035 ↗
• MalfunctionFeb 10, 2017Pumping Problem; Pumping Problem

  CUSTOMER OBSERVED THE PRODUCT HAD A CRACK BEFORE USE. (NO CONTACT WITH THE PATIENT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6323317 ↗
• MalfunctionFeb 10, 2017Pumping Problem; Pumping Problem

  PER CUSTOMER COMPLAINT REPORT, THE FLOPUMP CONTAINED CRACKS ON THE BASE OF THE PRODUCT. THE CRACK WAS NOTICED DURING PRIMING OF THE PUMP AND THE DEVICE WAS NOT USED WITH THE PATIENT AT ALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6322604 ↗
• MalfunctionAug 2, 2016Pumping Problem; Pumping Problem

  PER CUSTOMER COMPLAINT REPORT, THE FLOPUMP CONTAINED CRACKS ON THE BASE OF THE PRODUCT. THIS WAS NOTICED DURING PRIMING OF THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5842223 ↗
• MalfunctionFeb 4, 2016Pumping Problem; Pumping Problem

  PER CUSTOMER COMPLAINT REPORT, THE FLOPUMP EVIDENCED AN UNUSUAL NOISE AND LACK OF MINIMAL ROTATION AND REQUIRED REPLACEMENT DURING PROCEDURE. THE CUSTOMER COMPLAINT WAS RECEIVED BY IBC ON (B)(6) 2016.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5410359 ↗