July 27, 2023
FDA: Class I recall of Abbott Amplatzer Steerable Delivery Sheath
Editor's Note
The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious.
Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures with this device.
The company reports 26 incidents, 16 injuries, and no deaths related to this issue.
Distribution dates were October 4, 2022, to February 22, 2023.
Free Daily News
- Airborne bacteria pose hidden threat in cardiac ORs, study warns
- Simulation-based training boosts scrub nurses’ confidence in OR non-technical skills
- New AHRQ toolkit empowers OR teams to cut MRSA, SSI risk
- Study: Long working hours alter brain regions tied to emotion, cognition
- Survey: Burnout, rigid schedules push nurses to leave
- UCLA surgeons perform world’s first bladder transplant
- AHA urges HHS to cut regulations that burden hospitals and staff
- Commentary: Overlooking, underfunding perioperative mental health threatens patients
- Study: Fewer men undergo unnecessary prostate cancer surgery amid rise in active surveillance
- OpenAI benchmarking tool tests healthcare LLMs
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement