Here are 17 medical device and technology recalls, as reported by Becker’s so far in 2025:
Note: This list is not exhaustive.
- Abiomed issued a recall alert after identifying a cybersecurity risk with its Automated Impella Controllers.
- Olympus Corp. recalled its ViziShot 2 FLEX needles manufactured prior to May 12 after reports of the device components detaching during procedures.
- The FDA issued a safety alert for several models of Boston Scientific’s Endotak Reliance defibrillation leads after identifying a serious defect linked to 16 deaths and 386 injuries.
- Boston Scientific issued a recall of its Carotid Wallstent Monorail Endoprosthesis due to a manufacturing defect that could cause resistance during device withdrawal.
- Draeger recalled its SafeStar and TwinStar breathing system filters due to a risk of misleading carbon dioxide readings.
- Dexcom recalled 19 models of its continuous glucose monitoring receivers due to a speaker malfunction that could prevent alerts for dangerous blood sugar levels.
- Medline expanded a correction involving procedure kits containing its Medtronic aortic root cannulas, due to risk of serious injury or death.
- Smiths Medical issued a Class I recall for certain CADD-Solis and CADD-Solis VIP ambulatory infusion pumps due to multiple issues that could interrupt or delay medication delivery.
- BD and its subsidiary C.R. Bard issued a Class I recall for several esophagogastric balloon tamponade tubes because of difficulties in removing plastic plugs from the device’s rubber lumens.
- Abbott issued a recall for select HeartMate mobile power units used with its HeartMate3 and HeartMate III left-ventricular assist systems due to risk of sudden power loss that could lead to serious injury or death.
- Medtronic issued a recall for several aortic root cannula devices due to a potential safety risk that could cause loose material to dislodge during use, potentially leading to stroke or death.
- Smiths Medical recalled certain sizes of its Portex oral/nasal endotracheal tubes because of a manufacturing defect that results in a smaller diameter, which could potentially lead to inadequate ventilation.
- Medtronic recalled certain Pipeline Vantage Embolization Devices with Shield Technology due to an increased risk of incomplete wall apposition and braid deformation, which could lead to stroke or death.
- Baxter Healthcare issued a recall for some Spectrum infusion pumps due to a potential defect involving missing motor mounting screws, which could lead to interruptions, delays or incorrect dosing of medication.
- Johnson & Johnson MedTech issued a recall for its Biosense Webster Varipulse Bi-Directional Ablation Catheter following reports of strokes and transient ischemic attacks in patients undergoing procedures with the device.
- Boston Scientific recalled its Accolade pacemaker devices due to a manufacturing issue that could cause the devices to enter safety mode, requiring replacement.
- Abiomed, also known as Johnson & Johnson MedTech, issued a recall for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps due to safety concerns.
