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FDA Recalls: HeartWare HVAD Pump Outflow Graft

A compilation of key FDA recalls from the past week.

Each week, we highlight the top FDA recall publications. Here are recalls that may belong on your radar for the week of May 24, 2020:

Apotex Corp. Issues Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine

Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Read the full recall statement.

Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up

Medtronic is recalling their HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft of the HVAD Pump may tear and the strain relief screw may break during assembly prior to implant but might not be observed until during or after the pre-implant pump assembly and attachment to the HVAD pump.

The use of the affected products may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death.

Medtronic has received 92 complaints related to the pre-implant pump assembly process, which includes both the strain relief screw breaking and outflow graft tears.

Read the full recall statement.