Surgical Instruments

The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.

Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result

Due to a defect in the outer pouch sterile seal

Procedure Instruments with erroneous unit carton labels.

Procedure Instruments with erroneous unit carton labels.

Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.