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
- Hospitals boost cybersecurity budgets, staff
- Kentucky passes first-ever state law decriminalizing medical mistakes
- Kaiser Permanente data breach affects 13.4 million
- Study explores link between diverticulitis and colorectal cancer
- State lawmakers target rising healthcare costs via legislation on hospital facility fees
- FDA medical device Class 1 recalls trend upward
- Data cast doubt on recommendation to delay weight-loss meds prior to surgery
- AAMI guidance covers sterile processing of dilators, ultrasound probes
- Surgical site infections often caused by preexisting bacteria
- The Joint Commission launches new telehealth accreditation program
© Access Intelligence, LLC. All rights reserved. | Privacy Policy | Diversity, Equity, Inclusion & Belonging