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MedWatch Safety Alert

Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped

The HeartWare HVAD system pump is used in patients with heart failure. Some pumps had delayed or failed restarts, which may cause serious risk to patients.

2021 Medical Device Recalls

List of Medical Device recalls in 2021.

Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System

Medtronic plc , the global leader in medical technology, has voluntarily issued a global recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.

Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook

The Liko Multirall 200 Overhead Lift is a general-purpose lift to move patients from room to room.

Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit

EMBLEM S-ICD is an implantable defibrillator. In some devices, moisture may get inside and keep the device from shocking the heart to fix heart rhythm.

2021 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.

Adamssecret.co Issues Voluntary Nationwide Recall of Adam’s Secret Extra Strength 1500 and 3000 Capsules Due to Presence of Undeclared Sildenafil and/or Tadalafil

Adamssecret.co is voluntarily recalling all lots within expiry of Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafi

Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error

Medfusion 3500 and 4000 syringe pumps control fluid and drug delivery to patients. A software issue may cause over- or under- delivery, causing adverse events.