Device safety cluster: Omnipod 5, Abbott Libre, Dexcom, Tandem, Boston Sci, Medtronic, Allurion, Impella CP, Hintermann H3, AngioDynamics, Medline, Contec CMS8000, red light therapy, Hamilton Medical, Relay Pro, Olympus, J&J Impella, Abbott Proclaim, GE HealthCare, SNOO, Zoll, SCS MDL, Boston Sci Orca, Medtronic Octopus 4, plus new FDA warning letters for CPAP/3B Medical/AseptiKits, plus Glidesheath recall, plus Hologic BioZorb, plus Bard Access Systems and Provena catheter recalls, plus port device legal attention, plus Windstone Medical Packaging convenience kit recall
Key Questions
What is the status of the Omnipod 5 recall?
The Omnipod 5 recall has been escalated to FDA Class I after 24 serious injuries from tubing tears causing insulin under-delivery and DKA risk.
Which companies received recent FDA warning letters for device issues?
BMC Medical, 3B Medical, and AseptiKits received letters for unauthorized modifications, complaint handling failures, and misclassification of sterile kits.
What recalls affect Dexcom CGM devices?
Dexcom faces FDA warnings, recalls, and app corrections amid ongoing lawsuits related to glucose monitor accuracy and safety.
What caused the Medline cardiac surgery kit recall?
Medline issued a Class I recall for over 7,000 kits due to anesthetic contamination risks in cardiac surgery procedure kits.
Are there new concerns with port devices like Bard PowerPort?
Port device injuries are gaining legal attention through the Bard PowerPort MDL in Arizona, with FDA data showing specific injury patterns.
What is the Glidesheath Slender recall about?
Terumo's Glidesheath recall involves incorrect guidewire sizes, leading to 84 complaints and potential procedural complications.
Which other devices have recent Class I or serious recalls?
Hologic BioZorb (252 injuries), Windstone convenience kits (contamination), and Impella CP (1 death) are among recently escalated recalls.
What cybersecurity issues persist with medical devices?
Legacy devices from manufacturers like Medtronic, Boston Scientific, and others continue to face cybersecurity vulnerabilities requiring ongoing monitoring.
Expanded with Dexcom CGM lawsuits (FDA warning, recalls, app corrections), Medline cardiac surgery kits Class I recall (anesthetic contamination, 7,000+ kits), and FDA warning letters to BMC Medical (unauthorized G3X APAP modifications), 3B Medical (complaint handling failures), and AseptiKits (misclassification of sterile kits). New: Omnipod 5 recall escalated to FDA Class I – 24 serious injuries, tubing tear causing insulin under-delivery, risk of DKA, specific lot numbers. Also new: FDA warning letters to ZOLL, Medline, Happiest Baby (quality system failures, delayed MDR reporting). New: Glidesheath Slender Introducer Sheath recall (Terumo, incorrect guidewire size, 84 complaints). New: Hologic BioZorb Class I recall (252 injuries). New: Bard Access Systems Class 2 recall of soft tissue biopsy trays. New: Provena Midline Catheter Class 2 recall. New: Port device injuries gaining legal attention – Bard PowerPort MDL in Arizona, injury patterns, FDA data, legal consolidation. New: Windstone Medical Packaging convenience kit recall (Class I, contaminated alcohol prep pads with Paenibacillus phoenicis, specific model numbers/UDI codes, infection risk). Existing recalls: Omnipod 5 (7M pods), Boston Sci (4 deaths), Impella CP (1 death), Hintermann H3 (16.1% failure), Contec CMS8000 probe, red light therapy devices, Hamilton Medical, Relay Pro, Olympus endoscope infections, GE HealthCare, Zoll issues, SCS MDL. Cybersecurity concerns for legacy devices remain.