Agency classClass IOur severity:Severe FDA (Devices)·Z-2374-2023·Announced 2023-08-23

Dialysis Catheter Recall: Center Lumen Occlusion Due to Excessive Lubricant

Covidien LP is recalling MAHURKAR 12 Fr dialysis catheters due to center lumen occlusion from excessive lubricant. The defect may cause treatment delays and serious 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: FDA Class I classification indicates a serious health hazard with potential for significant patient harm. Although no illnesses or injuries have been reported, the defect poses a clear risk of treatment delays and serious medical complications including hemolysis, embolism, and thrombosis.

Plain-English summary

Covidien LP is recalling the MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter (Reference 8888103002HP, lot numbers 2133700232, 2133700247, and 2133700248) distributed nationwide in the United States and to multiple countries worldwide.

The center lumen of affected catheters contains an occlusion caused by excessive MDX, a silicone-based lubricant applied to the catheter tip during manufacturing. This defect may result in partial or complete catheter obstruction.

An occluded center lumen can cause treatment delays, reduced blood flow during dialysis sessions, and serious medical complications including hemolysis, embolism, and thrombosis. Dialysis patients using these catheters, healthcare facilities, and dialysis centers are directly affected.

The FDA classified this recall as Class I, indicating a serious health hazard. Patients and healthcare providers should immediately discontinue use of affected catheters and contact Covidien LP or their healthcare provider for replacement units.

The recalled product

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
Manufacturer: Covidien LP
Category: Medical Device — Dialysis / Hemodialysis Catheter
Hazard: catheter-occlusion
treatment-delay
embolism
thrombosis
hemolysis
Affected units: 299

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

GTIN: 20884521128023 LOT Numbers: 2133700232 2133700247 2133700248

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 · catheter occlusion