FDA medical device recalls

Abiomed's Impella Controller may display a delayed "Purge System Blocked" alarm when used with first-generation Impella 5.5 pumps. This could prevent timely detection of a blocked purge system. The issue affects 62 controllers with specific serial numbers in software versions 8.2.2 through 8.5.

Abiomed is recalling purge cassettes used in Impella heart pump systems because Generation 1 cassettes have an increased risk of leaking during use. This affects multiple Impella pump models sold globally, with specific batch numbers identified from 2024.

The surgical instruction guide for the Waldemar Link Embrace Drill Tower shoulder instrument contains mixed-up article numbers in the equipment overview section. The individual surgical steps themselves are correct and safe to follow.

Waldemar Link's Embrace Shoulder Instruments Drill Tower (25mm, Item 645-081/62) was distributed with a surgical technique guide that lists incorrect article numbers in the instrument overview. The step-by-step surgical instructions themselves are correct and safe to follow.

Medline Industries has recalled specific lots of Puracol and Puracol Plus collagen wound dressings due to elevated endotoxin levels. These contaminants can cause inflammation, tissue irritation, delayed healing, fever, low blood pressure, and in severe cases, septic shock.

The labeling on BD Alaris System with Guardrails Suite MX does not specify which version of Transport Layer Security (TLS) must be enabled on hospital networks for secure Wi-Fi communication with Point-of-Care Units. This could create confusion during setup and potentially leave devices with inadequate security settings.

Olympus discovered that some PKS Cutting Forceps (Model 920005PK) have defective welds in their components. During surgery, the forceps' jaw can break due to these weak welds, potentially affecting the procedure.

Olympus PKS Cutting Forceps (Model 920000PK) contain welding defects that can cause the instrument's jaw to break during surgery. The supplier did not properly validate the welding process on affected components. This affects 7 units distributed worldwide.

Olympus Corporation has recalled its PKS Cutting Forceps (Model 3005PK) used during minimally invasive surgery. The device contains components with defective welds that were not properly validated by the supplier. If the jaw breaks during use, it could affect the procedure and patient safety.

Olympus discovered that some HALO PKS Cutting Forceps (model HACF0533) have defective welds in their components. During surgery, the forceps' jaw can break when the welds fail, potentially affecting the procedure. This affects medical facilities worldwide that use these surgical instruments with the Gyrus ACMI G400 Workstation.

Olympus PK Cutting Forceps (model PK-CF0533) contain welding defects that can cause the instrument's jaw to break during surgical use. The supplier did not properly validate the welding process on affected components. This could compromise the forceps' function during endoscopic or open surgical procedures.

Olympus discovered that some Everest Bipolar Cutting Forceps (Model 3006) have welding defects in internal components. These defects can cause the forceps' jaw to break during surgery, potentially requiring additional procedures or intervention.

Olympus has recalled its Everest Bipolar Cutting Forceps (Model 3005) used in minimally invasive surgery because some units contain defective welds in their components. The jaw of the forceps can break during use due to these faulty welds. This affects 106 units distributed worldwide.

Tandem Diabetes Care insulin pumps distributed in the Czech Republic and Slovakia have translation errors in their Czech language user guide. The most serious error tells users to verify the infusion set is connected to the body when it should say the opposite—that it should NOT be connected. Following these incorrect instructions could cause unintended insulin delivery and dangerously low blood sugar.

Medtronic has recalled certain MiniMed 780G insulin pumps due to software defects that can cause the pump to deliver too much insulin, too little insulin, or stop delivering insulin entirely. These defects appeared after software updates (versions 6.60, 6.61, and 6.62) and may result in dangerously high or low blood sugar levels. The recall affects over 26,000 pumps with specific serial numbers.

AMO has recalled certain TECNIS Eyhance intraocular lenses (IOLs) used in cataract surgery because a small number may have a defect where the lens haptic (support arm) sticks to the optic, preventing proper unfolding during implantation. This affects 361 lenses distributed across 12 U.S. states. No injuries have been reported.

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Straumann USA LLC recalled certain Custom Abutment Ti units (catalog number 027.4620) because of a manufacturing error. A raw material bar made of TAN material was mistakenly labeled and used instead of the correct Titanium Grade 4 material during production. This affects 13 units distributed in the US and Canada.

Koven Technology's BiDop 3 Pocket Doppler ultrasound device was distributed with labeling that claims it can be used for fetal applications, but the FDA never approved it for that use. The device is only cleared to detect blood flow in blood vessels, not for fetal monitoring. Using it for unapproved purposes could lead to incorrect results or missed diagnoses.

Orthalign's Trimax Drill Plate (Size 6-7, REF 402567) in some units may cut bone larger than intended during knee surgery. The defect affects 7 units distributed in Utah. No injuries have been reported.

Orthalign drill plates (Trimax-Pegged, Sizes 1–5, REF 402566) in one lot may have been made outside specifications. This could cause bone cuts larger than intended during knee surgery. Seven units were distributed in Utah.

Philips is clarifying and updating labelling on certain X7-2 ultrasound transducers to better define their useful life in the field. This affects a small number of units distributed nationwide. No injuries have been reported.

Philips is clarifying labeling on certain X3-1 ultrasound transducers to better define their useful lifespan in clinical use. This affects a small number of devices distributed nationwide. No injuries have been reported.

Philips Ultrasound, Inc. is providing clarification and updated labeling for the S5-2 Ultrasound Transducer to define its useful life in the field. This affects a limited number of units distributed nationwide.

Philips is recalling certain S4-1 ultrasound transducers to clarify and update labeling that defines how long these devices can be safely used in clinical settings. No injuries have been reported. The recall affects 41 units distributed nationwide.

Philips is clarifying and updating labeling on certain OMNI III TEE ultrasound transducers to better define their useful life in the field. This is a precautionary measure affecting 75 units distributed nationwide.

Philips is clarifying the useful life labeling on certain OMNI II TEE Ultrasound Transducers to ensure healthcare facilities have accurate information about when these devices should be replaced. Two units with specific serial numbers (02P8MV and 02MH3J) were affected and distributed nationwide.

Philips is clarifying labeling on certain Mini Multi TEE Ultrasound Transducers to better define when these devices should no longer be used in clinical settings. The affected units may lack clear guidance on their useful lifespan, which could affect safe operation.

Philips is clarifying labeling on certain L17-5 Ultrasound Transducers to better define their useful life in clinical use. This affects 2 units with specific model and serial numbers distributed nationwide. No injuries have been reported.

Philips is clarifying and updating labeling on certain L12-5 ultrasound transducers to better define their useful life in the field. This affects 40 units distributed nationwide. No injuries have been reported.