Guidewire product recalled by Centerline due to potential for coating to remain inside patients, posing a risk.
The Food and Drug Administration (FDA) has announced a Class I recall for guidewires manufactured by Centerline Biomedical, marking the first entry for the company in the FDA’s database of devices that have been removed from the market or corrected due to faults.
The Centerline IOPS Guidewire ATW-2, a medical device used to aid in the placement of catheters and other devices within blood vessels and body cavities, falls under the regulatory category of guidewires. This category has also seen recalls for products from other manufacturers, such as Abbott, Boston Scientific, Cook Medical, Teleflex, and more.
The recall for Centerline's guidewires is due to a fault where the coating of the guidewires can come off during use, potentially causing serious injury or death. The affected devices have sensors that connect to an intraoperative positioning system to help navigate through vessels and place catheters in target locations.
In April, Centerline Biomedical issued the recall notice, asking customers to return affected devices from certain lots. According to the FDA, there are 80 units of the affected guidewires in commerce in eight states. The company has mitigated the risk by removing the faulty devices from the market.
Previously, in March, Centerline received FDA clearance for an updated version of the system, comparing it to a predicate device made by Abbott's St. Jude Medical. However, the specific date for the Class I recall is not given.
Other guidewire recalls have typically been for issues such as device breakage or tip separation, coating defects or separation, incorrect measurement performance, and potential for patient injury during use. For instance, the Abbott PressureWire™ X Guidewire was recalled due to potential device failures affecting accuracy in measuring pressure during cardiac procedures.
If you want details on a specific recall or regulatory data, the FDA’s MAUDE database or recall database can be searched for guidewire-related recalls, which would provide up-to-date and detailed information. It is worth noting that the FDA has stated that no customers have reported serious injuries or deaths associated with the fault in Centerline's guidewires.
This development comes amidst other recalls in the same regulatory category. For example, Medtronic has recently recalled ventilators linked to 2 serious injuries and 1 death. Companies including Abbott, Baxter, Boston Scientific, Edwards Lifesciences, GE Healthcare, and Siemens Medical Solutions have also recalled products in the same category as Centerline's system.
As always, healthcare professionals and patients are advised to consult the FDA's official communications and guidance for the latest information on medical device recalls and safety updates.
- The FDA's database now includes Centerline Biomedical, following a Class I recall of their guidewires, marking the company's entry in the database of devices withdrawn or corrected due to faults.
- The recalled guidewire, the Centerline IOPS Guidewire ATW-2, is a medical device used for navigating through vessels and placing catheters, categorized under guidewires.
- The recall was issued due to a fault in the coating of the guidewires, which could come off during use, posing a risk of serious injury or death.
- In response to the recall, Centerline issued a notice in April, asking customers to return the affected devices from certain lots.
- According to the FDA, there are 80 units of the recalled guidewires in commerce in eight states.
- Besides Centerline, other manufacturers like Abbott, Boston Scientific, Cook Medical, Teleflex, and more have also had guidewires recalled due to various issues.
- In the realm of healthcare and wellness, it's crucial for medical professionals and patients to stay updated on recalls and safety updates by consulting the FDA's official communications and guidelines. This is particularly important in the context of medical-conditions and therapies-and-treatments, given the importance of AI, medtech, and science in modern healthcare.
