Alerts

On 8 September 2022, the US Food and Drug Administration issued a safety communication about reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants.

MiniMed 600 and 700 series Insulin Pumps - Medtronic - Loss of power due to cracked or damaged battery cap.

Medtronic Cobalt and Crome ICDs and CRT-Ds - software update required

Update

This page contains the original recall in June 2021 and progress updates to 2024.

Update - suspension lifted after review

Product defect correction - lid magnet may dislodge and cause early battery depletion

Patients may be injured if they wear face masks (such as surgical or non-surgical masks and respirators) with metal parts and coatings during an MRI examination

Update - Suspended breast implant devices now cancelled

List of alerts on potential issues when used for uterine surgery in patients with fibroids

Hazard alert - titanium modular necks pose small risk of fracture

Update on FDA post-approval study

Product defect correction – risk of delayed therapy due to potential battery issues

Recall of multiple products - potential for breaches of sterile packaging

Update - interim results from FDA surveillance studies

Expert working group was held to provide recommendations on acute care ventilator post-market review

Update to information

Safety information for intragastric balloon systems

Hazard alert - potential for components to separate

New suspension - Medtronic Puritan Bennett 980 Series Ventilator

Recall - potential risk of harm for children who access the button battery

Hazard alert and recall for product correction - urgent software updates needed

Update following revocation of suspension

Safety advisory – risk of serious injury or death due to incorrect instruction artwork

Recall for product correction - potential for injury due to breakage of the seating system