Here are three recent medical device and prescription drug recalls reported to the FDA:
1. Olympus recalls endoscope needles
Olympus is recalling its ViziShot 2 FLEX needles manufactured before May 12 after reports of component detachment during lung biopsy procedures. The device is used with ultrasound endoscopes for lung cancer diagnosis. One patient injury and one death have been reported. Olympus has implemented automated inspections to replace manual visual checks.
2. Abiomed alerts users to heart pump controller vulnerability
Abiomed issued a recall alert for its Automated Impella Controllers, which operate Impella heart pumps, after identifying cybersecurity risks. If exploited, the vulnerabilities could lead to unexpected pump stop or loss of control, potentially resulting in serious injury or death, the FDA said. No patient harm or cyberattacks have been reported. The devices may continue to be used once disconnected from network access.
3. Teva recalls blood pressure drug over cancer risk
Teva Pharmaceuticals voluntarily recalled more than 580,000 bottles of prazosin hydrochloride after detecting N-nitroso Prazosin impurity C, a probable carcinogen. The Class II recall was posted Oct. 30 and includes bottles with levels exceeding FDA’s acceptable intake limits. The drug is used to treat high blood pressure.
