Sarns™ Centrifugal Pump with X-Coating™ CV-164275XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753450349), received between Jun 7, 2016 and Jun 7, 2016 — classified as 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K112229); 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.

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.

• MalfunctionJun 7, 2016Packaging Problem; Packaging Problem

  IT WAS REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING A NON-CLINICAL ACTIVITY THE PACKAGING OF THE CENTRIFUGAL PUMPHEADS WAS DEFECTED. THE WIDTH OF THE STERILE SEAL WAS BELOW SPECIFICATION BY .8MM. THIS OCCURRED DURING A NON-CLINICAL ACTIVITY; THEREFORE, THERE WAS NO PATIENT OR SURGICAL EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5703054 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112229. One submission often covers many models, so check the product and lot details in each record.

• Z-1235-2017 · May 27, 2015 · Terminated
  The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-ste
• Z-2030-2014 · Apr 14, 2014 · Terminated
  Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 7
• Z-2028-2014 · Apr 14, 2014 · Terminated
  Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
• Z-2029-2014 · Apr 14, 2014 · Terminated
  Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.