Tennessee recalls

Certain lots of the Abiomed Impella CP Set with SmartAssist (10th Generation) and its 14Fr Low Profile Introducer Kit may form blood clots during extended use. The affected units have specific serial numbers and batch numbers listed by the FDA. No injuries have been reported.

Abiomed has recalled certain low-profile introducer kits used with its Impella CP heart support device due to a potential risk of blood clot (thrombus) formation during prolonged use. The recall affects 17 units distributed in select US states and Japan.

Abiomed's 14 Fr x 13 cm Low Profile Introducer Kit for the Impella CP heart pump may increase the risk of blood clot (thrombus) formation during extended use. Three units have been distributed to hospitals in the US and Japan.

Medline Industries identified unapproved design changes to 10mL syringes in certain C-Section Tray convenience kits that were not cleared by the FDA under the original product authorization. The affected kits were distributed nationwide and to Barbados.

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified in ways that were not approved by the FDA. These design changes were not part of the original FDA clearance for these products. The kits are used in medical settings for procedures like central line insertion, vascular access, and fistula management.

Medline Industries identified unapproved design changes in certain 10mL polycarbonate colored syringes used in medical convenience kits. These changes were made outside the FDA-cleared design and were not originally reported to the FDA. The affected kits were distributed nationwide to healthcare facilities.

Medline Industries recalled over 113,000 convenience kits containing 10mL polycarbonate colored syringes used in cardiac and interventional radiology procedures. The firm made design changes to the syringes that were not approved by the FDA in the original product clearance. These kits were distributed nationwide.

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified with design changes that were not approved by the FDA. These kits are used in surgical and medical procedures including cataract surgery, vascular interventions, and spine procedures.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified in ways that were not approved by the FDA. The changes were made outside the scope of the FDA clearance originally granted for these products.

Medline Industries identified that certain 10mL polycarbonate colored syringes included in Major Basin Set convenience kits (model DYNJ85723) were modified in ways that were not approved by the FDA. These design changes were made outside of the FDA clearance process. Approximately 113,843 kits containing these syringes have been distributed nationwide.

Medline Industries identified that certain surgical convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The kits were distributed nationwide and include craniotomy, spine, laminectomy, and neuro packs used in operating rooms.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes used in neurological and angiography procedures contained design changes that were not reviewed or cleared by the FDA. These products were distributed nationwide and include multiple SKUs across neuro packs, angio packs, and related surgical kits.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The kits were sold nationwide and include various surgical and procedural trays used in hospitals and medical facilities.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Dr G's Breast Pack, Lipo Supplement Pack-LF, and Plastic Pack products distributed nationwide.

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Medline Industries identified that certain medical convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not reviewed or approved by the FDA. These kits are used in cardiac catheterization, angiography, and other medical procedures. The firm has initiated a recall of affected lots.

Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Angiogram Pack-LF and Judkins Pack models distributed nationwide.

Boston Scientific has recalled one INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to the potential for leakage along the drug pathway from the pump through the catheter end. This is an implantable device used to deliver medication directly to the liver. The affected device was distributed in Ohio.

Philips Telemetry Monitor 5500 (model 867232) devices may unexpectedly reset to a default state, causing them to lose their configuration settings and disconnect from the hospital's central monitoring system. This could prevent the monitor from reconnecting to the PIC iX central system until manually reconfigured.

Zimmer discovered that 12 units of the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Size 9/9+, 10mm thickness) contained an incorrect posterior augment component in the package instead of the correct distal augment. No patient injuries have been reported.

During manufacturing, Medtronic discovered that tubing was installed backwards on some Octopus 4 Tissue Stabilizer devices: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This affects 590 units with specific serial numbers distributed nationwide.

Medtronic identified a manufacturing defect in certain Octopus Evolution AS Tissue Stabilizer units where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite the correct design. This incorrect assembly could affect proper operation during surgical use. The issue affects 288 units distributed worldwide.

Medtronic identified a manufacturing defect in certain Octopus Evolution Tissue Stabilizer units where the tubing was installed backwards: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This incorrect assembly could affect the device's proper function during use.

Certain lots of Dexcom G7 continuous glucose monitoring sensors that were designated for destruction were stolen and later sold to pharmacies and distributors without authorization. Two affected lots have different risks: one was not properly sterilized and poses an infection risk, and the other may not provide accurate readings or detect dangerous blood sugar levels.

Surgify Medical's Halo 5.4 mm burr (Model 54.140.SHD.U1) used in spinal surgery may break during the procedure. This could leave fragments inside the surgical site or require additional intervention. The issue affects all lots distributed in the US until an updated instruction document is provided.

Surgify Medical's Halo 5.4 mm burr, used in minimally invasive spinal surgery, may break during use. The company has identified this risk and is notifying healthcare facilities.

Surgify Medical's Halo 5.4 mm burr (model 54.125.NVG.U1) may break during bi-portal endoscopic spinal surgery. The company has identified this risk and is working to update instructions for use. No injuries have been reported.

Surgify Medical's Halo 5.4 mm burr (Model 54.125.NVG.H1) may break during bi-portal endoscopic spinal surgery. The device has been distributed across multiple U.S. states. No injuries have been reported.