FDA medical device recalls

Hard drives in Philips Azurion imaging systems may degrade after six years of use, potentially causing loss of imaging capability. In some cases, the system may need to be restarted to restore function temporarily. Philips has identified this issue in multiple Azurion models used in medical facilities.

GE HealthCare has identified a situation where the ApexPro CARESCAPE Telemetry Server (versions 5.0 and 6.0) can lose ECG and SpO2 monitoring data if the system loses network connection to the central monitoring station. This affects 14 units used in hospitals and clinical settings.

GE HealthCare identified a rare condition in CARESCAPE Telemetry Server v5.0 and v6.0 where a persistent network communication failure at the central monitoring station can result in loss of ECG and SpO2 (heart rhythm and blood oxygen) monitoring. The problem occurs only when the system is in a "NO COMM" or "OFF NETWORK" state at the central station.

A limited number of Medtronic 2x4 Pocket Adaptor Kits (Models 64001 and 64002) were labeled with incorrect Use-By-Dates. The affected kits are used with deep brain stimulation systems to treat parkinsonian tremor. No injuries have been reported.

Devicor Medical Products is recalling HydroMARK Breast Biopsy Site Marker Model 4010-02-15-T3 due to incorrect labeling on individual packages inside boxes. Some boxes labeled as T3 markers may contain packages labeled as T4 markers, which could lead to use of the wrong marker type during a breast biopsy procedure.

Certain Impella Controller (AIC) consoles contain electrical faults including alarm failures, power-path problems, and inaccurate motor sensing. Additionally, improper alignment between the purge cassette and motor drive can prevent the purge system from priming correctly, requiring users to switch to a backup console.

Medline distributed multiple spinal anesthesia and nerve block procedure kits containing Bupivacaine Hydrochloride in Dextrose Injection made by Huons Co. The anesthetic was recalled due to quality concerns, including problems with microbiology testing data and reports that the medication may not work as expected.

Halyard Purezero Ultraviolet Nitrile Exam Gloves in sizes XS through XL failed to meet chemical permeation performance standards, meaning they may not provide adequate protection against certain chemicals. This affects approximately 452,500 units distributed nationwide.

Abiomed identified that certain Automated Impella Controller (AIC) units have internal hardware issues that could affect device operation. These include cable and component positioning problems that may interrupt motor controls, cause startup failures, or prevent the device from booting properly. Abiomed is implementing hardware updates through its servicing process.

The proximal clasp on Bolton Medical's RelayPro Thoracic Stent-Graft System may disconnect from the outer control tube during use. This disconnection could prevent the stent graft from being released properly from its delivery system. The FDA has issued a labeling update to inform physicians and hospitals of this potential issue.

A rubber hose inside the X-ray tube cooling unit (type CU3101) on certain Philips Integris-Allura systems can degrade and leak oil over time. This reduces cooling performance and causes the system to automatically switch to low-dose mode with a "Tube cooler problem" message that cannot be cleared by restarting. The affected cooling units were manufactured between February 2016 and May 2020.

A cooling hose in certain Philips Allura X-ray systems manufactured between February 2016 and May 2020 may degrade over time and leak oil. If oil leakage reduces cooling performance below a safe threshold, the system automatically switches to low-dose fluoroscopy and cannot be fixed by restarting.

A cooling hose in certain Philips Azurion X-ray systems may degrade over time and leak oil, reducing cooling performance. When oil levels drop too far, the system automatically switches to low-dose mode and cannot be fixed by restarting.

C.R. Bard has recalled certain Silastic Brand Foley Catheters (5cc and 30cc models) due to staining on the catheter surface. The affected catheters were distributed across the U.S. and Canada.

Certain Philips Azurion fluoroscopy systems may experience mechanical wear in the Float Tabletop control, which could impair the longitudinal and transverse (side-to-side and front-to-back) movement of the examination table. This wear could affect the system's ability to position patients correctly during imaging procedures.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94965), a cardiopulmonary bypass catheter, may have a breach in the sterile barrier that protects the device before use. This affects 260 units distributed worldwide, including in the United States.

Certain lots of the Medtronic DLP Retrograde Cannula (Model 94915), a catheter used during heart bypass surgery, may have a breach in their sterile packaging. This could allow contamination before the device is used. No injuries have been reported.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94913L), a catheter used in heart surgery, may have a compromised sterile barrier. This could allow contamination during the surgical procedure. The issue affects 481 units distributed worldwide.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94913), a catheter used in heart-lung bypass surgery, may have a compromised sterile barrier. This could allow contamination before use. The affected product was distributed worldwide, including the United States.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94725), a catheter used in heart surgery, may have a breach in their sterile packaging. This could potentially expose the device to contamination before use. The affected lots have been identified by lot number and GTIN code.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94665) used in heart-lung bypass surgery may have a compromised sterile barrier. This could allow contamination of the device before use. The affected lots have been identified and distributed worldwide.

Certain lots of Medtronic DLP Retrograde Cannula (Model 94215T), a catheter used during heart surgery, may have a compromised sterile barrier. This affects 600 units distributed worldwide. No injuries have been reported.

Certain lots of Medtronic GUNDRY Retrograde Cannula (Model 94115T), a catheter used during heart-lung bypass surgery, may have a breach in their sterile packaging. This could allow contamination of the device before use. The affected lots have been identified and are listed in the recall notice.

Certain lots of Medtronic GUNDRY Retrograde Cannula (Model 94113T), a cardiopulmonary bypass catheter, may have a breach in the sterile barrier. This could allow contamination of the sterile product before use during heart surgery.

The straight inserter tool on certain OneLIF Interbody Cage implants may fail to attach properly to the cage. This could prevent secure engagement during spinal fusion surgery, potentially causing procedural delays or requiring surgeons to choose a different implant.

ICU Medical oncology infusion kits with extension sets may develop leaks during chemotherapy administration. If a leak occurs during therapy, patients may receive less medication than intended, and healthcare workers or patients could be exposed to hazardous drugs.

Tangent Endoscopy's Single Use Digital Catheter (models TNG4002-IND and TNG-4007-6pk) can develop fractures at the tip of the shaft during use. While the fractured pieces have not completely detached in reported cases, a broken catheter tip could affect device function or potentially cause patient harm.

Certain Swan-Ganz Pacing Catheters (Model D200F7) may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This can result in infection, medication loss, or blood loss during use.

Certain Swan-Ganz Jr Catheter models may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This can result in infection, loss of medication, or blood loss during use.

Certain Swan-Ganz catheters may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This defect can result in loss of medication, blood loss, or infection during use.