Sapphire Connect Power Supply 15072-121-1055Recalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17290109154494), received between Jan 25, 2024 and Jan 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K192860); 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Overheating of Device1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 25, 2024Overheating of Device; Overheating of Device
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM THE USA. POWER SUPPLY ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18578162 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192860. One submission often covers many models, so check the product and lot details in each record.

Z-0094-2024 · Sep 11, 2023 · Open, Classified
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

Device details

UDI-DI	`17290109154494`
Brand	Sapphire Connect Power Supply
Model	15072-121-1055
Company	Eitan Medical Ltd
Product code	MRZ · Accessories, Pump, Infusion
Class	Class 2
FDA submission	K192860
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Apr 3, 2023

Device type (GMDN): Basic power supply, reusable

A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.

Other Accessories, Pump, Infusion devices

Medfusion 4000-0106-01
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls4,390 reports
Medfusion 4000-0105-51
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls2,882 reports
CADD 21-2111-0401-51
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
4 recalls461 reports
CADD 21-2112-0402-78
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
3 recalls0 reports
MEDFUSION 4000-0106-00
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls10 reports
Medfusion 3500-0600-00
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls9 reports
Medfusion 3500-0600-51
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls2 reports
Medfusion 4000-0105-78
Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
2 recalls0 reports

All Accessories, Pump, Infusion devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page