FDA updates device failure linked to Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps
Editor's Note The Food and Drug Administration (FDA) on November 19 updated the device failure associated with Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps (IABPs) in a letter to health care providers. Since 2017, the FDA has received more than 75 reports of the IABPs shutting down while running on battery. Five…
FDA: Class I recall of Zimmer Biomet’s ROSA Brain 3.0 Robotic Surgery System
Editor's Note The Food & Drug Administration on November 7 identified the recall by Zimmer Biomet of its ROSA Brain 3.0 Robotic Surgery System as Class I, the most serious. The recall was initiated because of a software issue that incorrectly positions the robotic arm. The company has received five…
FDA: Class I recall of Philips Medical System’s Forte Gamma Camera System
Editor's Note The Food & Drug Administration (FDA) on November 4 identified Philips Medical System’s (Cleveland) recall of its Forte Gamma Camera System as Class I, the most serious. The recall was initiated because of the potential for the detector, which weighs 660 pounds, to become detached from the device…
FDA: Class I recall of Abbott CentriMag Circulatory Support System
Editor's Note The Food and Drug Administration on November 4 identified the recall by Abbott of its CentriMag Circulatory Support System as Class I, the most serious. The recall was initiated because of a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop,…
FDA: ICU Medical recalls Lactated Ringer’s Injection, 0.9% Sodium Chloride Injection
Editor's Note The Food & Drug Administration on October 30 announced the nationwide recall by ICU Medical (San Clemente, California) of one lot of Lactated Ringer’s Injection, USP, and one lot of 0.9% Sodium Chloride Injection because of the presence of particulate matter. The affected lot numbers are: Lactated Ringer’s…
FDA: Class I recall of Ethicon Echelon Flex Endopath staplers
Editor's Note The Food & Drug Administration on October 30 identified the recall by Ethicon of its Echelon Flex Endopath staplers as Class I, the most serious. The recall was initiated because of failure of the staplers to completely form staples. As of October 3, 2019, seven serious injuries and one…
Proactive steps paramount for greater surgical stapler safety
Internal surgical staplers made headline news in 2019. Reports discussed the little-known US Food and Drug Administration database housing tens of thousands of stapler-related problem reports and covered the agency’s recent proposal to reclassify staplers as Class II devices, instead of the more lightly regulated Class I. ECRI Institute named…
FDA: Class I recall of Medtronic’s 6 French Sherpa NX Active Guide Catheters
Editor's Note The Food & Drug Administration (FDA) on October 8 announced the recall by Medtronic of all models of its 6 French Sherpa NX Active Guide Catheters. Medtronic is recalling the catheters because of the risk of the outer material separating from the device, resulting in detached fragments that…
FDA: Class I recall of Allergan Natrelle Biocell textured breast implants
Editor's Note The Food & Drug Administration (FDA) on September 12 designated the recall by Allergan of its Natrelle Biocell textured breast implants as Class I, the most serious. The recall was initiated because of a six times higher rate of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer…
FDA: Metrix Company recalls certain lots of empty flexible IV bags
Editor's Note The Food & Drug Administration on September 10 posted the recall by the Metrix Company of Dubuque, Iowa, of specific lots of its empty IV flexible containers (bags) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names. The recall was initiated because of the potential…
Free Daily News
- Hospital addresses barriers to patient rest, recovery
- Study: Psilocybin therapy reduces depression in frontline clinicians
- Exclusive articles preview OR Business Management Conference sessions
- Study: Surgeries improve survival in young BRCA-positive breast cancer patients
- Study: Advanced recovery room care could reduce long-term postoperative mortality
- FDA designates Class 1 recalls for balloon catheters, radiographic markers
- Orthopedic surgery in 2025: Embracing innovation, preserving autonomy
- Medtronic, Zimmer Biomet challenge Intuitive Surgical’s robotic surgery dominance
- Anthem’s anesthesia time limit policy, reversal sparks new legislation
- Simple procedure or ‘surgery’? Questionable medical billing practices cause confusion