Medical device manufacturer Centerline issues recall for guidewires due to potential hazard of coating being implanted in patients' bodies
Centerline Biomedical has issued an urgent medical device recall notice for its IOPS Guidewire ATW-2, used in vascular procedures. This is the first Class I recall for Centerline in the FDA's database of devices that have been removed from the market or corrected because of faults.
The recall is due to a fault that could cause serious injury or death. The guidewire may delaminate during use, potentially leaving part of the device inside the patient. The FDA published a Class I recall notice due to the potential for serious harm.
The FDA's regulatory category for Centerline's system and the devices recalled by companies such as Abbott, Baxter, Boston Scientific, Edwards Lifesciences, GE Healthcare, and Siemens Medical Solutions may differ. However, other recalls of guidewires—including devices similar to Centerline's IOPS Guidewire ATW-2—have been classified as Class II, indicating a risk of temporary or medically reversible harm or a remote risk of serious harm.
No customers have reported serious injuries or deaths associated with the fault. The coating of the guidewires can come off during the procedure and be left inside the patient. There are 80 units of the affected guidewires in commerce in eight states.
Examples of Recalls in the Same Regulatory Category (Guidewires/Endovascular Devices)
- Cook Medical Lunderquist Extra-Stiff Wire Guidewires
- Recall Reason: Fracture risk during use
- Recall Classification: Class II
- Summary: Potential for wire fracture could lead to embolism or other complications.
- Terumo Radifocus Guidewire
- Recall Reason: Tip deformation causing device malfunction
- Recall Classification: Class II
- Summary: Tip deformation can impact procedural effectiveness and patient safety.
- Medtronic Glidewire Guidewire
- Recall Reason: Striping of hydrophilic coating
- Recall Classification: Class II
- Summary: Coating separation may lead to foreign body embolism.
- Abbott Vascular Hi-Torque Guidewire
- Recall Reason: Guidewire kinking/breakage
- Recall Classification: Class II
- Summary: Risk of vascular injury or wire retention.
Classification Definitions
- Class I: Most serious recall; reasonable probability of causing serious adverse health consequences or death.
- Class II: Moderate risk; may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.
- Class III: Least serious; unlikely to cause adverse health consequences.
It's worth noting that the FDA awarded 510(k) clearance to Centerline's positioning system in 2019, based on a comparison to a predicate device made by Abbott's St. Jude Medical. Healthcare professionals use Centerline's IOPS Guidewire ATW-2 in the placement of catheters.
The recall of Centerline's guidewires is not related to the ventilators recalled by Medtronic. The FDA has not issued any Class I recalls for Medtronic's ventilators, despite them being recalled due to 2 serious injuries and 1 death. The FDA's database does not specify the number of devices recalled by companies other than Centerline.
- The FDA is urging healthcare professionals to immediately cease using the IOPS Guidewire ATW-2 from Centerline Biomedical, due to a Class I recall.
- In health-and-wellness news, Centerline's guidewire recall is noteworthy as it marks the first Class I recall for the company in the FDA's database.
- AI-driven medical analytics have indicated that the fault in Centerline's IOPS Guidewire ATW-2 could lead to potentially serious injury or death.
- In the realm of medtech, the FDA has designated a Class I recall for Centerline's IOPS Guidewire ATW-2 due to the possibility of serious harm.
- Despite no reported severe injuries or deaths, the recall is prompted by the risk of the device's coating delaminating, potentially being left within patients.
- As reported by health science, Centerline's IOPS Guidewire ATW-2 recall is part of a larger trend of guidewire recalls, many of which have been classified as Class II, indicating a risk of temporary or reversible harm.
- With the IOPS Guidewire ATW-2 recall, Centerline Biomedical joins companies like Abbott, Boston Scientific, and Medtronic in medical-conditions-related news, due to the removal or correction of devices due to faults.
