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HemoSphere

Edwards Lifesciences LLC · Model HEMOXSC100 · UDI-DI 00690103196986

DQE DQK QAQ MUD DXN DSB QMS FLL Prescription

510(k) clearances

1,067

Adverse events (24 deaths)

Recalls

Facilities

Description

HemoSphere Oximetry Cable

Recalls

Date	Firm	Reason
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2020-03-27	Edwards Lifesciences, LLC	Sterile catheter kit packaging compromised.
2020-01-02	ICU Medical, Inc.	Inability for the guidewire to pass through the needles included with the catheter kits.
2020-01-02	ICU Medical, Inc.	Inability for the guidewire to pass through the needles included with the catheter kits.
2020-01-02	ICU Medical, Inc.	Inability for the guidewire to pass through the needles included with the catheter kits.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.