Healthcare Business

America's Unsafe Medical Products

Paul Ausick

Faulty Hematology Analyzers Recalled
> Issue date: May 23, 2019
> Type of alert: Recall

Beckman Coulter Live Sciences is recalling 3,428 UniCel DxH 800, UniCel DxH 600, and UniCel DxH 900 Coulter Cellular Analysis Systems that may sporadically report elevated platelet counts without notifying the test operator.

Increased Death Rates for Users of Pulmonary Support System
> Issue Date: May 21, 2019
> Type of alert: Update

In a post-approval study of Abiomed’s Impella RP system, the survival rate of 28.6% (12 of 42 enrolled patients) was much lower than the premarket clinical study survival rate of 73.3%. The FDA acknowledged that the device’s benefits continue to outweigh the risks in selected patients.

Use of Unapproved Devices for Diabetes Management
> Issue date: May 17, 2019
> Type of alert: Safety communication

The FDA is warning diabetes patients and health care professionals against using devices such as glucose monitors and insulin dosing systems that have not been reviewed by the FDA to ensure that such devices are both effective and safe. See the FDA website for more details.

Oral Suspension Treatment Recalled for Possible Contamination
> Issue date: May 12, 2019
> Type of alert: Recall

Novartis is voluntarily recalling three lots of Promacta 12.5 mg oral suspension due to possible contamination from peanut flour. No Promacta tablets are included in the recall. See the FDA website for additional details.

Safety Notice Related to Premature Battery Depletion in Pacemakers
> Issue date:

May 7, 2019
> Type of alert: Safety communication

The FDA is alerting health care providers, caregivers and patients about issues that may cause batteries in some Medtronic implantable pacemakers and cardiac resynchronization therapy pacemakers that may cause the batteries to drain more quickly than expected without warning either patients or health care providers. The full list of affected Medtronic devices is given in the FDA’s safety communication.

Recall of Tainted Erectile Dysfunction Capsules
> Issue date: May 7, 2019
> Type of alert: Recall

Stiff Boy has voluntarily recalled all lots of its The Beast capsules. The capsules are tainted with sildenafil, an FDA-approved drug for treatment of erectile dysfunction. Because the drug is present, The Beast capsules are regarded as an unapproved drug and subject to recall.

Recall of Anti-Inflammatory Drug Ketorolac Tromethamine Injection
> Issue date: May 3, 2019
> Type of alert: Recall

Sagent Pharmaceuticals is voluntarily recalling one lot of its non-steroidal anti-inflammatory drug (NSAID) due to the possibility that the drug may not be sterile.