Prosthesis, Tracheal, Expandable（JCT）

Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction. ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.

Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction. ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. This was the only complaint received for this non-conformance.

Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.