Agency classClass IOur severity:Severe FDA (Devices)·Z-2386-2023·Announced 2023-08-23

MAHURKAR dialysis catheters recalled for center lumen occlusion risk

Covidien LP recalls MAHURKAR dialysis catheters due to excessive silicone lubricant on the catheter tip, which can obstruct the center lumen. This may delay treatment and cause serious blood complications including embolism and thrombosis.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as Severe because it is an FDA Class I medical device recall, which requires a minimum severity score of 4. Although no illnesses or injuries have been reported, the device poses significant risk of serious complications including hemolysis, embolism, and thrombosis in dialysis patients.

Plain-English summary

Covidien LP is recalling MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheters, 16 cm with Curved Extensions (REF: 8888345611). The recall affects 69,987 units distributed nationwide and internationally. Specific affected lot numbers have been identified by the manufacturer.

The center lumen of affected catheters can become partially or fully occluded due to excessive coating of MDX, a silicone-based lubricant applied to the catheter tip. This occlusion can prevent normal fluid flow through the catheter or cause particulate matter to dislodge.

An obstructed or partially obstructed catheter may delay treatment and reduce blood flow. Particulate dislodgement from the catheter could cause hemolysis (destruction of red blood cells), embolism (blood vessel blockage), or thrombosis (blood clot formation).

Healthcare providers should check affected dialysis catheters by lot number against the recall list. If a recalled catheter is identified, do not use it. Contact Covidien LP for replacement units or additional information about this recall. No injuries or illnesses have been reported related to this issue.

The recalled product

Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Manufacturer: Covidien LP
Category: Medical Device — Dialysis Catheter
Hazard: obstruction
embolism
thrombosis
hemolysis
Affected units: 69,987

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 25 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 25 products in this recall →

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Same hazard · obstruction