According to a recall announcement on fda.gov, the U.S. Food and Drug Administration has issued a Class I recall affecting Covidien, LLC (Medtronic)Palindrome and Mahurkar Hemodialysis Catheters. Class I recalls are the most severe type of product recall. The use of these medical devices can lead to very serious injuries or death. The recall announcement states that the affected Palindrome and Mahurkar Hemodialysis Catheters have a potential leaking condition inside the hub of the recalled chronic dialysis catheters.
The manufacturing dates of the recalled Palindrome and Mahurkar Hemodialysis Catheters include June 1, 2017, through April 1, 2022. These products were distributed from June 28, 2017, until 11, 2022. There are about 1,032,377 devices being recalled in the U.S.
The FDA announcement states that the affected Palindrome and Mahurkar catheters are implanted and used during hemodialysis. Hemodialysis is a treatment that filters waste and water from a patient’s blood). The catheters are also used in apheresis treatments and infusion procedures.
Covidien, LLC recalled its Palindrome and Mahurkar catheters because of a catheter hub defect. The defect can cause a leaking condition inside the hub of certain chronic dialysis catheters. This can cause the flow of fluid through the catheter tip to return unanticipated fluid. This leak may cause a mixing of venous and arterial blood, leading to increased poor dialysis and recirculation, thrombi, and emboli.
Using a recalled catheter could cause severe adverse medical outcomes, such as bleeding, removal, and replacement of the defective catheter. So far, there has been one complaint and no reports of injury or death.
On June 8, 2022, Covidien, LLC issued an Urgent Medical Recall Letter to impacted customers, telling them of the medical device’s issue and probable risks to health. Covidien, LLC is urging customers to:
- Immediately discontinue the recalled chronic hemodialysis catheters.
- Immediately quarantine the recalled medical devices.
- Follow facility-specific procedures concerning hemodialysis patency, function, and efficacy.
- To identify fluid contamination by flushing one extension tube.
- If fluid contamination is discovered, the patient’s medical team must use their clinical judgment to determine the timing and necessity of a replacement catheter.
- Return recalled lots of chronic hemodialysis catheters.
- Forward the information from the recall letter to whom the products have been delivered.
- Complete the Consignee Product Retrieval Confirmation Form even when there aren’t any unused catheters.
- Share the recall notice with all medical professionals within your organization.
- Retain this notification for your records.
Customers may also contact Medtronic Technical Services at medtronic.com. A complete list of recalled devices can be found in the Medical Device Recalls database.
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