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U.S. Department of Health and Human Services

Class 1 Device Recall SHERPA NX ACTIVE GUIDING CATHETER

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 Class 1 Device Recall SHERPA NX ACTIVE GUIDING CATHETERsee related information
Date Initiated by FirmMarch 15, 2019
Date PostedOctober 01, 2019
Recall Status1 Terminated 3 on April 26, 2024
Recall NumberZ-2713-2019
Recall Event ID 82525
510(K)NumberK042489 K132673 
Product Classification Catheter, percutaneous - Product Code DQY
ProductSHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0 SH, .070", REF SA6JR50SH. for cardiovascular use
Code Information GTIN: 00613994821799 All Lot/Serial Numbers
Recalling Firm/
Manufacturer
Medtronic Vascular
35 Cherry Hill Dr # 37a
Danvers MA 01923-2565
For Additional Information ContactJoey Lomicky
978-777-0042
Manufacturer Reason
for Recall
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 Determined
Cause 2
Component design/selection
ActionMedtronic 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.
Quantity in Commerce105 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = DQY
510(K)s with Product Code = DQY
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