CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report

Mahurkar"* Elite Acute Dual Lumen Dialysis Catheter recalled

Medtronic Minimally Invasive Therapies Group is recalling Mahurkar"* Elite Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. The recall was initiated on 14 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 10884521126473/20884521126470 Lot: 1717900160.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1007-2018
FDA event ID: 79319
Recalling firm: Medtronic Minimally Invasive Therapies Group, Mansfield, MA
Classification: Class II
Status: Terminated
Recall initiated: 14 Oct 2017
FDA classified: 14 Mar 2018
Reported: 21 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

14 Oct 2017	Recall initiated by company
14 Mar 2018	Classified by FDA	+151 days
21 Mar 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

Where it was distributed

U.S.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 10884521126473/20884521126470 Lot: 1717900160.

Where was it sold?

U.S.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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