Living with device safety

Stories from people navigating device safety — diagnosis, treatment, caregiving, and the ordinary days in between.

7 stories

An automated Impella controller undergoing an identification-label check in a hospital cardiac procedure area.

Cardiology

Impella Controller Recall: Immediate Cath Lab Checks

Cardiac procedural teams should reconcile every automated Impella controller against the FDA-listed removal, including units in use, storage, transport kits and biomedical engineering custody.

Rayan Salih · November 11, 2026 · 7 min

A transcatheter valve delivery system prepared on a sterile structural-heart procedure table.

Cardiology

FDA Flags Edwards Mitral Delivery-System Safety Issue

An FDA early alert concerns an Edwards transcatheter mitral-valve delivery system, but key scope and response details remain unavailable to structural-heart teams.

Rayan Salih · 6 min read

Cardiology

Edwards Mitral Valve Delivery-System Alert Needs Review

An FDA early alert flags an Edwards transcatheter mitral-valve delivery system, but the available record does not name a model, event count or corrective action.

Dr. Abu Bakar · 6 min read

Neonatal CPAP tubing and cannula components arranged for a hospital inventory safety check.

Health Policy

FDA Class I Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets

An FDA Class I recall covers specified CooperSurgical INCA infant nasal CPAP set lots because tubing-to-cannula connections may loosen and interrupt respiratory support.

Dr. Abu Bakar · 6 min read

Quarantined medical convenience kits and saline ampules in a hospital supply room

Innovation & Devices

AVID Medical Kits Require Class I Saline Quarantine

The Class I correction applies to affected AVID Medical convenience kits containing Huons sodium chloride ampules. Facilities should quarantine stock, trace prior use and assess possible exposures.

Dr. Abu Bakar · 6 min read

Astral ventilator beside a checked backup ventilator and organized respiratory equipment in a clinical room.

Innovation & Devices

Astral Ventilator Class I Recall Raises Backup Needs

Supercapacitor electrolyte leakage may damage circuit boards in affected ResMed Astral ventilators. Ventilator-dependent patients need a functional backup and a rehearsed response plan.

Rayan Salih · 6 min read

Packaged vascular devices being checked against a recall notice in a hospital supply area

Innovation & Devices

ENROUTE Class I Recall Requires Immediate Lot Review

Specified ENROUTE neuroprotection system lots were recalled after arterial sheath tip separation reports. Transcarotid teams should quarantine inventory and review potentially affected procedures.

Rayan Salih · 6 min read

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