Medical Devices Recalls

St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.

Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.

Sterilization validation failure.

Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit¿ du Medicament et des produits de sant¿ (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).

Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.

the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.