Medical device recalls

Abiomed has recalled certain Introducer Kit 23 Fr units (Pump Set Code 1000441) due to a potential for sheath leakage from under the sheath cap and along hub score lines. This manufacturing issue cannot be seen by the user and affects introducers included in every pump set.

Abiomed has recalled the Impella CP Introducer Kit (Pump Set Code 1000550) worldwide due to a potential for fluid leakage from under the sheath cap and along hub score lines in the 14Fr and 23Fr introducers. The leakage defect is not visible to the user and affects all current batches of this heart pump accessory kit.

Abiomed has recalled the Impella CP heart pump introducer due to a manufacturing defect that can cause fluid leakage from under the sheath cap and along the hub. The defect is not visible to the user and affects all current batches worldwide.

The Abiomed Impella RP Flex heart pump set includes introducers that may leak fluid from under the sheath cap or along hub score lines due to manufacturing defects. These leaks cannot be seen by visual inspection. All current batches worldwide are affected.

Abiomed's Impella Hemostatic Peel Away Introducer Kit (models 14Fr and 23Fr) may leak from the sidearm, under the sheath cap, or along hub seams due to manufacturing defects. The affected products were distributed in Massachusetts. No injuries have been reported.

Oscor Inc. has recalled certain Abiomed Impella Hemostatic Peel Away Introducer Kits (models 14Fr and 23Fr) due to manufacturing defects. The introducer sheaths may leak from the sidearm, under the sheath cap, or along hub score lines during use.

Abiomed's Impella Introducer Kit (Hemostatic Peel Away Introducer System) may have manufacturing defects that cause the 14Fr and 23Fr introducer sheaths to leak from multiple locations: the sidearm, under the sheath cap, and along hub seams. This affects 355 units distributed in Massachusetts.

Certain sterile tourniquet extension hoses may have a breach in the sealing area of the sterile pouch, which could allow contamination. If used without detection, the hose could potentially cause a moderate localized infection at the surgical site.

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

W L Gore & Associates has recalled specific batches of the GORE TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation during use. This is a surgical implant used to repair certain aortic conditions. The separation could potentially affect the device's ability to function as intended.

Masimo Corporation is recalling certain Radius VSM Disposable NIBP Cuff devices due to two issues: the ECG electrode may incorrectly detect abnormal heart rhythms in patients with normal heart rates, triggering false alarms that can distract clinicians; and small and medium-sized blood pressure cuffs may have rough edges that can irritate skin. These issues could delay proper treatment or patient discomfort in healthcare settings.

Masimo Corporation recalled its Radius VSM ECG pre-connected Set due to two issues: the ECG electrode assembly may incorrectly detect abnormal heart rhythms in patients with normal heart rates, triggering false alarms that can distract clinicians from real patient concerns; and small and medium blood pressure cuffs may have rough edges that can irritate skin.

Laborie Medical Technologies' Solar GI System water perfusion devices may accumulate moisture inside tubing, filters, and pressure sensors during extended clinical use. This moisture buildup can affect how the system measures airflow and pressure, potentially impacting test results.

Bard Access Systems is recalling soft tissue biopsy trays (Models 4380 and 4382A) because the lidocaine ampoules included in the kits were manufactured under deficient manufacturing practices. The affected trays are used by healthcare providers to collect tissue samples from patients.

Bard Access Systems is recalling certain Provena Midline Catheters because the lidocaine ampoules included with them were manufactured under deficient manufacturing practices. The catheters are used for short-term intravenous therapy, blood sampling, and contrast media injection. The defect affects multiple sizes and configurations across worldwide distribution.

Several models of Bard PowerPICC catheters included lidocaine ampoules (small vials) that were manufactured under deficient manufacturing practices. The lidocaine supplier has issued a recall of these ampoules due to quality concerns.

Lidocaine ampoules supplied with Bard's Groshong NXT ClearVue Catheter were manufactured under deficient practices. The supplier has initiated a recall of the affected ampoules due to these manufacturing concerns.

PowerPICC Provena peripheral catheters supplied with lidocaine ampoules manufactured under deficient manufacturing practices. The lidocaine ampoules are being recalled by the supplier due to quality concerns. These catheters are used for intravenous therapy, blood sampling, and central venous pressure monitoring in healthcare settings.

Bard Access Systems is recalling PowerMidline Catheters (4 Fr Dual-Lumen) because the lidocaine ampoules included with these devices were manufactured under deficient manufacturing practices. The affected catheters were distributed nationwide and internationally.

Bard Access Systems is recalling PowerMidline Catheters because the lidocaine ampoules (small vials) included with these catheters were manufactured under deficient manufacturing practices. The affected catheters are used for short-term intravenous access and blood sampling.

Bard Access Systems is recalling certain Power-Trialysis Slim-Cath short-term dialysis catheters because the lidocaine ampoules included with them were manufactured under deficient practices. The affected catheters are used to provide temporary vascular access for dialysis and related treatments.

Bard Access Systems is recalling multiple lots of Power-Trialysis short-term dialysis catheters because the lidocaine ampoules included with them were manufactured under deficient manufacturing practices. The affected catheters come in straight, curved extension, and Alphacurve styles with model numbers 5605150, 5605240, 5605300, 5615120, 5615200, and 5655120.

Bard Access Systems is recalling PowerPICC SV catheters (both 3 Fr and 4 Fr models) because the lidocaine ampoules included with these catheters were manufactured under deficient practices. These catheters are used for central venous access during intravenous therapy and blood sampling.

Bard Access Systems is recalling PowerPICC SOLO HF Catheters (5 Fr Triple-Lumen) because the lidocaine ampoules included with the kit were manufactured under deficient manufacturing practices. The affected lot (REKT1554) was distributed nationwide and internationally.

The lidocaine ampoules included with Bard's DuoGlide Short-Term Dialysis Catheters were manufactured under deficient practices and are being recalled by the supplier. The affected catheters are used for temporary vascular access during hemodialysis and related therapies.

Bard Access Systems is recalling Poly Midline Catheter kits (models CK000495A and CK000566) because the lidocaine ampoules included with them were manufactured under deficient practices. These catheters are used for short- or long-term peripheral venous access in hospitals and clinical settings.

Bard Access Systems is recalling three models of thoracentesis and paracentesis drainage trays because the lidocaine ampoules included in these kits were manufactured under deficient manufacturing practices. The affected trays are used to remove fluid from the chest or abdominal cavity during medical procedures.

BD Switzerland inadvertently shipped 50 engineering sample units of the Medline 111 Gravity Set with 3 Needle Free Y-Sites into the U.S. market. These units were labeled "Not for Human Use" and were not intended for patient care. No injuries have been reported.

The Shiley Disposable Decannulation Plug (DDCP), a red connector used on tracheostomy tubes to block airflow, carries labeling that incorrectly indicates it does not contain DEHP (a chemical compound). The product actually contains 30–35% DEHP. Users relying on the label may not be aware of DEHP exposure during use.

Certain Zeiss Intrabeam Spherical Applicator 1.5 cm units used in intraoperative radiation therapy did not meet manufacturing specifications. A total of 13 units were affected across the United States, Puerto Rico, and several other countries. No injuries have been reported.