- Medtronic's Covidien unit was given another Class I label by the Food and Drug Administration for a recent recall of Puritan Bennett 980 series ventilators, the fourth Class I recall for the product since 2015.
- The recall, which was initiated March 25, is due to audible alarms potentially not sounding and/or the LED visual alarm potentially not displaying during an alarm state, according to an entry in the FDA’s device recall database. The agency said, “Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.”
- Medtronic said in an emailed statement that there “have been no reports of patient harm and the frequency of occurrence is unlikely.” According to the database entry, the recall affects over 35,000 units, 18,508 units outside of the U.S. and 16,563 in the U.S.
The March recall is yet another product safety problem for the PB980 series ventilators.
In November, Medtronic conducted a recall due to a manufacturing error, forcing the company to ask physicians to immediately stop the use of the machines and quarantine the impacted units until they could be inspected and have affected parts replaced. There were six complaints and one death reported due to the issue, according to the FDA.
There were also Class I recalls for the product in 2014, 2015 and 2018.
In 2018, the Covidien unit updated software to address user interface issues with machines. The update came after Australia suspended the supply of the devices for over one year beginning in September 2017.
The Therapeutic Goods Administration, which is part of Australia’s Department of Health, suspended supply of the devices after several reports of the screens going black, user interfaces not responding and unexpected shutdowns or restarts. The TGA ultimately lifted the suspension in November 2018 with a list of conditions for Medtronic to adhere to, including updating the wording of warnings and instructions in user manuals.
For the most recent recall, Medtronic is “advising that continued use of PB980 ventilators is appropriate and provided guidance to customers,” the company said in the statement.
In March, Medtronic sent an alert to customers regarding the issue, saying that there had been 17 reports of sound or visual alarm issues, and in 13 of the reports “it was stated that the patient was transferred to an alternative source of ventilation with no patient harm,” according to the recall alert provided to MedTech Dive by the watchdog group ECRI.
Medtronic has had ongoing recall and product safety issues for the last several years. Among the list are numerous Class I recalls, pulling a heart device off the market after recalls and reports of patient harm mounted and an FDA warning letter for the diabetes group for safety problems.
CEO Geoff Martha addressed recalls at the J.P. Morgan healthcare conference in January, saying that it was his "top priority" and the company would be “increasing accountability and aggressively accelerating plans to enhance patient safety and improve our quality performance.”
The ventilator recall was not the only one Medtronic initiated last month that was ultimately labeled Class I by the FDA, which is the severest recall labeling.
In March, Medtronic began a recall of delivery catheters for the Harmony transcatheter pulmonary valve system, which is used to treat the part of the heart that carries blood to the lungs. The delivery catheter is the device that implants the replacement valve without open-heart surgery.
The FDA said in the notice that the recall was “because it is possible that the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the transcatheter pulmonary valve.” The recall affected 665 units.
The agency said that there were six reported complaints from clinical cases, one injury and no deaths.