Sapphire 1638401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787007449), received between Apr 29, 2020 and Apr 29, 2020 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier.

8 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.

Recalls naming this device

1. Jul 29, 2019Terminated

   Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

   Z-0134-2020 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionApr 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY SAPPHIRE¿ INFUSION SET, 1.2 MICRON FILTER, PAV, 123 INCH THAT DURING TESTING, AIR PASSED THROUGH THE FILTER AND DOWN THE LINE. THE CUSTOMER REPORTED THAT THE FILTER DID NOT CATCH THE AIR. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 10011706 ↗

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-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-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-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-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-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-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-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