B. Braun Medical and Zimmer Biomet have recalled their medical devices.

B. Braun Medical Inc. has issued an urgent correction for its Infusomat Space Infusion System and related products, including the Large Volume Pump Wireless and Non-Wireless Battery Pack. The FDA has classified this recall as the most serious type due to the risk of serious injury or death if the devices are used without correction.

The recall affects the Infusomat Space Infusion System, the Infusomat Space Large Volume Pump Wireless, and the Non-Wireless Battery Pack. The issue involves a malfunction where the alarm may indicate a blockage (occlusion) when none exists, potentially stopping the delivery of critical medications. This expanded recall adds the Infusomat Space Infusion System to previously affected models. B. Braun Medical Inc. began notifying affected customers on August 6, 2024 and has recommended interim measures to mitigate risks.

For B. Braun Medical Inc., addressing this issue promptly is crucial to maintaining customer trust and avoiding further complications or liabilities. The corrective measures aim to prevent serious adverse health consequences and ensure patient safety, thus protecting the company’s reputation and minimizing financial impact.

In addition, the FDA has released a safety communication regarding the Zimmer Biomet CPT Hip System Femoral Stem, highlighting an elevated risk of thigh bone fracture (postoperative periprosthetic femoral fracture) linked with this device. Zimmer Biomet has initiated a voluntary recall to update instructions for use and plans to phase out the device by December 2024. The FDA is concerned about continued use in new patients and is collaborating with Zimmer Biomet to address these issues.

Zimmer Biomet’s CPT Hip System, including the Femoral Stem 12/14 Neck Taper, has been found to have a higher risk of thigh bone fracture compared to similar devices. A recent analysis showed a fracture rate of approximately 1.4% with this device, higher than the 0.6% to 1% range seen with comparable products. Zimmer Biomet is working on updating usage instructions and plans to discontinue the device. Addressing these concerns promptly is critical for patient safety and maintaining trust in their products.