Sapphire 1632402Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787007265), received between Oct 23, 2019 and Oct 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K171346); 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.

• MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT NDEHP SAPPHIRE SET NV +1.2 FILTER WAS LEAKING. IT WAS FURTHER DESCRIBED BY THE CAREGIVER THAT TPN WAS LEAKING OF THE FILTER AND BLOOD HAD REFLUXED DOWN THE TUBING ALL THE WAY TO THE FILTER AND WAS ALSO LEAKING, RESULTING A PATIENT BEING SOAKED IN TPN AND BLOOD. THERE WERE ALSO SOME LARGE AIR SECTIONS VISIBLE CLOSER TO THE PATIENT THAN THE FILTER. THIS OCCURRED 1.5 HOURS AFTER THE IV PUMP WAS STARTED. THE PUMP SET ON 6PSI. THE PUMP DID NOT AUDIBLY ALARM. THE PATIENT HAD TO BE CLOSELY MONITORED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9227215 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171346. One submission often covers many models, so check the product and lot details in each record.

• Z-0129-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit
• Z-0135-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore,
• Z-0133-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, C
• Z-0130-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118
• Z-0132-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, P
• Z-0147-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore,
• Z-0131-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 11
• Z-0134-2020 · Jul 29, 2019 · Terminated
  Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 1
• Z-0619-2019 · Nov 8, 2018 · Terminated
  SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a conta