Medical Devices Recalls

***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

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

Weak skin adhesion.

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

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.

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.

Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

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

Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels

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