Sapphire 1636202Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887787007357), received between Oct 14, 2019 and Mar 7, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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-0130-2020 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionMar 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A NDEHP SAPPHIRE MIC NV +0.2FLTR. IT WAS REPORTED A LEAK OCCURRED FROM ONE OF THE SMALL PERFORATIONS ON THE IN-LINE FILTER. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM-AS PER THE ONCOLOGY PHARMACIST, THE MEDICATION ALSO LEAKED ONTO THE PATIENT'S T-SHIRT, NO SKIN IRRITATION WAS REPORTED. THE PATIENT WAS ADVISED TO THROW THAT T-SHIRT IN THE GARBAGE. THE TEAM WAS WEARING PPE FOR THIS INTERVENTION.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862904 ↗
• MalfunctionOct 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A NDEHP SAPPHIRE MIC NV +.02FLTR THAT THE CUSTOMER REPORTED LEAKING AN UNKNOWN CHEMOTHERAPY MEDICATION FROM THE FILTER AREA. THERE WAS PATIENT INVOLVEMENT HOWEVER NO REPORT OF ADVERSE EVENT OF A DELAY IN THERAPY. THIS REPORT CAPTURES THE FIRST OF 2 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9184529 ↗
• MalfunctionOct 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A NDEHP SAPPHIRE MIC NV +.02FLTR THAT THE CUSTOMER REPORTED LEAKING AN UNKNOWN CHEMOTHERAPY MEDICATION FROM THE FILTER AREA. THERE WAS PATIENT INVOLVEMENT HOWEVER NO REPORT OF ADVERSE EVENT OF A DELAY IN THERAPY. THIS REPORT CAPTURES THE SECOND OF TWO DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9184511 ↗

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-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-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-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-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-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-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