A Class I recall has been issued for the Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device, including numerous products containing the Q-Syte Luer Access Split Septum Device, the U.S. Food and Drug Administration (FDA) just announced. The recalled items were repackaged and distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.

The FDA advised hospital risk managers that this Class 1 recall involves certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products, including kits and trays, sold by other companies in which the Q-Syte Luer Access device is a component. More Class I Recall for BD Q-Syte Luer Access Split Septum Device Products

A Class I recall has been issued by Gyrus ACMI, Inc. for Micron Bobbin Vent Tube T, 1.27 mm. The recalled device is intended to be implanted for ventilation or drainage of the middle ear.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. More Class I Recall for Gyrus ACMI Ear Device

Teleflex Incorporated has issued a worldwide voluntary recall of all lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010.

Teleflex’s Arrow International subsidiary initiated this field corrective action in February 2010 and included notification to customers by letter. Customers were directed to immediately quarantine affected devices and call the Arrow Custom IV Tubing hotline at 866-396-2111 to arrange for product return. More Teleflex Recalls Arrow IV Products, Arterial Embolectomy Catheters

Boston Scientific is issuing a massive recall of its implantable heart defibrillators. According to a Boston Scientific press release, the company is halting sales and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because it did not get approval from federal regulators for changes to its manufacturing processes.

All of the devices in the recall were acquired by Boston Scientific in 2006 when it purchased medical device manufacturer Guidant Corp., of St. Paul, Minn., for $28.4 billion. The recall impacts seven brands of Boston Scientific defibrillators: COGNIS®, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL®, TELIGEN® and VITALITY™. The Company’s pacemakers and other products are not affected by the is action. More Boston Scientific Recalls Seven Brands of Implantable Defibrillators

Third-party outsourcing of medical device approval is under review, the Wall Street Journal is reporting. Apparently, medical device makers—the Journal cited Philips Electronics NV, Siemens AG, and General Electric Co., for example—do not necessarily need to start the approval process with the U.S. Food and Drug Administration (FDA) and can have third-party companies handle such reviews. These reviews are then typically approved by FDA officials, the Journal noted.

This fast-tracking has been met with great criticism, and the agency is considering putting an end to the process, citing review quality and the original purpose for these types of reviews, said the Journal, which was to save taxpaying Americans money. More FDA Weighing Future of Third-Party Device Review

The U.S. Food and Drug Administration (FDA) just issued a warning targeted to surgical services managers, and risk managers regarding counterfeit flat sheets of polypropylene surgical mesh, which are used in the repair of hernias and chest wall defects. The counterfeit surgical mesh products are being marketed in the United States and are labeled with the C. R. Bard/Davol brand name.

According the FDA, these products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturers’ polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit. More FDA Warns On Counterfeit Surgical Mesh

Several medical device makers are being investigated by the U.S. Justice Department over the marketing of surgical-ablation devices. According to The Wall Street Journal, these devices are widely used to perform atrial fibrillation, but have not been cleared by the Food & Drug Administration (FDA) for this procedure.

Boston Scientific Corp., Medtronic Inc. and St. Jude Medical Inc. have all confirmed that they are the subject of such probes, the Journal said. Elaine George, a former medical-device saleswoman, has whistleblower lawsuits pending against the three firms alleging they marketed surgical-ablation devices for the unapproved use of fixing these faulty heartbeats. Though the government hasn’t joined her suits, her lawyer asserts the Justice Department began investigating these issues because of her litigation. More Justice Department Investigating Marketing of Surgical-Ablation Devices

Abiomed, Inc.’s recall of its AB5000 Circulatory Support System has been deemed a Class I recall by the Food & Drug Administration (FDA). Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The AB5000 Circulatory Support System supplies power to disposable blood pumps used to support the left and/or right sides of the heart. According to the recall notice, the computer may shut down (stop pumping) without an alarm. This defect may cause serious injuries or death. More Abiomed AB5000 Circulatory Support System in Class I Recall

The Torflex Transseptal Guiding Sheath has been recalled under a Class I recall by the Baylis Medical Company Inc., the U.S. Food and Drug Administration just announced. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

During heart procedures, the sheath tip may break off and separate while the sheath is in the blood vessels. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart. This could lead to unplanned open heart surgery, permanent injury, such as a stroke or heart attack, and/or death. More Class I Recall for Baylis Medical Torflex Transseptal Guiding Sheath

DePuy Orthopaedics, a unit of Johnson & Johnson, warned last week that its ASR artificial hip implant appears to have a high early failure rate in some patients. This warning came months after DePuy announce it was phasing out the ASR for declining sales.

According to a report in The New York Times, the warning from DePuy followed more than two years of reports that the device was failing in patients only a few years after implant, requiring costly and painful replacement operations. More DePuy Issues Warning on Hip Implant Device