Recalls
J&J’s latest Impella recall tied to 3 deaths, 37 injuries
Johnson & Johnson's Abiomed business initiated a latest recall due to component failures in automated Impella heart pump controllers, a problem linked to 3 deaths and 37 serious injuries. The FDA issued an early alert on Wednesday, recommending removal of the affected controllers from use or sales locations.
BD recalls intraosseous needle sets associated with 4 deaths
BD announced a recall of specific lots of its intraosseous vascular access system needle sets due to dimensional deviations that may cause difficulty in removing the obturator, potentially delaying treatment in emergency scenarios. The FDA has issued an early alert, and BD has confirmed the root cause and implemented corrective actions.
Boston Scientific removes stroke prevention catheter after injury
Boston Scientific is recalling certain catheters used for stroke prevention treatment due to concerns about the risk of the catheter tip separating during procedures. The U.S. Food and Drug Administration (FDA) issued an early alert on Friday, with one related injury reported as of July 9. The company has sent letters to customers instructing them to stop using or distributing the affected devices.
Resmed ventilator safety issue linked to 5 serious injuries
The US FDA reported on Wednesday that Resmed has contacted customers regarding an issue with Astral 100 and Astral 150 ventilators, linked to 5 serious injuries. Some devices may unexpectedly enter a fail-safe state and stop treatment, posing a risk of serious injury or death. Resmed notified customers on June 25, recommending continued use but with precautionary measures. As of June 23, the company reported 5 serious injuries and no deaths. Due to limited circuit board supply, Resmed will implement phased corrective actions and advises healthcare facilities to prioritize screening for high-risk patients.
Medtronic recalls heart valve delivery catheter for risk of tip detaching
Medtronic is recalling specific lots of the Harmony Transcatheter Pulmonary Valve Delivery Catheter System worldwide because the distal tip of the product may detach, potentially requiring additional surgery to retrieve the detached part. The U.S. Food and Drug Administration (FDA) issued a recall notice on Monday, classifying this action as a Class I (highest risk level) recall. As of May 14, Medtronic has not reported any serious injuries or deaths related to this issue.
Terumo recalls stent-graft system linked to three deaths
Terumo announced on Wednesday the recall of specific models of its RelayPro thoracic aortic stent graft system because physicians were unable to successfully separate the delivery system from the implanted stent during procedures, an issue linked to three deaths. The recall involves approximately 7,000 non-bare stent devices sold from May 2024 to March 2026 across 43 countries in North America, Latin America, Europe, the Middle East, and Asia. A similar recall was initiated in the Japanese market in early June.
FDA updates Hologic BioZorb recall, citing 252 injuries
The U.S. Food and Drug Administration (FDA) has updated recall information for Hologic BioZorb absorbable markers, reporting a total of 252 related injury events with no fatalities. Hologic ceased shipments in September 2024 and no longer manufactures the device. The FDA reiterates that healthcare providers should not use BioZorb markers, but removal of already implanted markers is not required.
FDA posts early alert over device used with Impella heart pumps
The U.S. FDA issued an early alert on Thursday noting a leakage risk in catheter introducers manufactured by Abiomed, a Johnson & Johnson company, and its manufacturing partner Oscor, which could lead to major bleeding in patients using Impella heart pumps. There have been 8 reported major bleeding events, and 3 death complaints, though assessed as unrelated to the leakage. Hospitals may continue using existing inventory, but physicians should be vigilant about potential leaks and consider device replacement or use of repositioning sheaths.
Zoll receives FDA warning letter over quality concerns
The U.S. Food and Drug Administration (FDA) issued a warning letter to Zoll Medical Corporation on April 30, citing MRI compatibility issues in some of its portable ventilators and deficiencies in complaint handling and device validation. Zoll, a subsidiary of Asahi Kasei, is headquartered in Chelmsford, Massachusetts. The company responded that it is confident in product quality and does not expect supply to be affected.
Johnson & Johnson's Abiomed Issues Hardware Correction for Impella Controllers, FDA Classifies as Class I Recall
Johnson & Johnson's Abiomed issued a hardware correction for Impella heart pump controllers, involving four potential safety issues. The U.S. FDA classified it as a Class I recall because the issues could lead to interruption or delay in hemodynamic support, potentially causing serious injury or death. As of April 14, no related injuries or deaths have been reported.