A recent NBC News investigation reveals that C.R. Bard’s Recovery blood-clot filter has been associated with 27 deaths and hundreds of serious injury reports.

The first of the part of the report discusses the numerous injuries that accumulated after market release, while the second part discusses how the blood-clot filter received FDA clearance.

Inside the report, a C.R Bard insider offers input and questions how the agency could have allowed the blood-clot filter to go to market. The C.R. Bard insider and regulatory specialist Kay Fuller was recruited by the company in 2002 to help guarantee FDA approval after the agency turned down the device’s previous applications.

According to Fuller’s interview, she had serious concerns about the Recovery blood-clot filter after a small human clinical trial raised major concern. In addition to the study’s troubling results, C.R. Bard reportedly did not disclose important safety performance results.

When Fuller voiced her concerns, Bard reportedly ignored them and had threatened to fire her if she pursued the questions any further. Even though Fuller stated she would not sign the application until her concerns were resolved, Bard reportedly submitted the application with an alleged forged signature that was supposed to be from Fuller.

Even though Fuller resigned form C.R. Bard, she voiced her concerns to the FDA and hoped that the Recovery blood-clot filter would not gain clearance.

The FDA would not confirm whether or not the agency acted on Fuller’s warning but that it did take her comments “very seriously”, especially when it came to “forgeries and device issues.”

C.R. Bard states that these allegations are completely untrue, and markets the Recovery blood-clot filter to be a safe device.

Overview of Recovery Blood-Clot Filter Problems

The Recovery blood-clot filter is an IVC (inferior vena cava) filter, which is directly placed in the inferior vena cava. These small cage like devices are meant to prevent blood-clot attacks in patients who cannot handle anticoagulant therapy.

These devices work by stopping blood-clots that form in the legs or hips, and prevent them from traveling to the heart or lungs.

However, there have been numerous allegations of reversible IVC filter models breaking apart and causing serious injury to patients. The Recovery blood-clot filter is one of the IVC filters allegedly causing problems for patients that Fuller and other experts believe could have been prevented.

Recently a confidential study was conducted by an outside doctor, which was also obtained by NBC News. The results indicated that the Recover blood-clot filter had an elevated risk for death and other IVC filter complications like filter fracture, compared to its competitors.

The doctor concluded that further investigation was “urgently needed.”

C.R. Bard sold approximately 34,000 Recovery blood-clot filter models. Some of these models have been linked to 27 deaths and several hundred injures over the past decade. Bard sold the Recovery blood-clot filters until 2005, until replacing them with a modified version with a new title.

Numerous patients have stated that they never would have opted for the Recovery blood-clot filter if they had known the risks. Many patients who were affected by these IVC filter complications have filed legal action against the manufacturers for failure to warn.

Save