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SHERPA NX ACTIVE recallZ-2613-2019 · Medtronic Vascular · initiated Mar 15, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Vascular or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

FDA root cause category: Component design/selection

What the company is doing

Medtronic initiated immediate communications to consignees on 15-Mar-2019. Consignees were asked to quarantine and/or return unused affected product, and confirmation of the immediate notification was requested per local requirements. In the US, Medtronic representatives notified consignees. Consignees were asked to return a Customer Confirmation Certificate. On 11-Apr-2019, Medtronic initiated the US follow up communications via hand-delivery and UPS 2-day delivery mailings to the March 2019 notification consignees and risk managers identified as part of the April 2019 scope expansion. Consignees are asked to quarantine and return unused affected product. The consignees are asked to return a confirmation form, acknowledging they have received the notification and have taken the requested action. Beginning 10-May-2019, Medtronic initiated additional communications via UPS 2-day delivery to 23 consignees in the US who were mailed the April 2019 notification with inaccurate product inventory reports. This communication included updated customer inventory reports. Communication was also initiated via UPS 2-day delivery to one consignee who did not receive the April 2019 notification, but did receive affected product. The consignees were asked to quarantine and return unused affected product. The consignees are asked to return a confirmation form, acknowledging they have received the notification and have taken the requested action. Beginning 10-Jun-2019, communication and retrieval activities will be initiated with all consignees who have received affected product (original and expanded scope) according to Medtronic records. Consignees will be asked to quarantine and return all unused affected product within their possession. Consignees will be asked to confirm receipt of this June 2019 FCA notification even if they have already confirmed notification of previous communications.

Recall details

Recall number
Z-2613-2019
Status
Terminated
Initiated by the company
Mar 15, 2019
Posted by the FDA
Oct 1, 2019
Recalling firm
Medtronic Vascular
Quantity
6 units
Product code
DQY
FDA submissions
K042489, K132673
Distribution
Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

Product description

SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular use

Code information (models, lots, serial numbers)

GTIN: 00613994822796  All Lot/Serial Numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

194 devices cleared under K042489, K132673 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 82525).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page