Dive Brief:
- Getinge is recalling some of its life support devices due to problems with sterile packaging that could pose an infection risk to patients.
- The recall includes all of Getinge’s Quadrox Oxygenators, which are used during bypass procedures or extracorporeal membrane oxygenation. It also includes some of the company’s venous hardshell cardiotomy reservoirs, which collect and filter blood during bypass surgery.
- Getinge sent a letter to customers in May telling them to remove any devices not currently in use. The Food and Drug Administration flagged the recall in a June 9 notice, advising healthcare providers to use alternative devices for new extracorporeal circulation procedures.
Dive Insight:
Sweden-based Getinge makes devices for surgery and critical care, including ventilators and circulatory support systems. In its letter to healthcare providers, the company said packaging may have holes or dents or smaller pinholes that aren’t visible and could compromise the device’s sterility. Getinge added it had not yet received any complaints or reports of injuries due to the problem.
The FDA has not yet classified the recall. The agency said it would monitor for any adverse events and would work with hospitals to help ensure they have alternative oxygenators.
Medtronic, Abiomed and Abbott all make similar machines cleared by the FDA, which can replace the recalled Getinge devices, according to a list provided by regulators.
The recall is a continuation of packaging problems reported by Getinge since it put a shipping hold on its heart lung support set in December due to the potential for compromised sterility.
A notified body based in Germany temporarily suspended CE certificates for the sets after finding it was no longer in compliance with the European Union’s Medical Device Directive. A second notified body in March suspended sales of Getinge’s Cardiosave intra-aortic balloon pump over concerns with risk management, post-market surveillance and the timeliness of corrective actions.
A spokesperson for Getinge couldn’t immediately be reached for comment.
The company’s shares closed little changed at 247 Swedish kronor ($22.82) on Monday in Stockholm.
