—#172058

Product

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular use

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K042489, K132673
Affected lot / code info: GTIN: 00613994823908 All Lot/Serial Numbers

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Medtronic Vascular
Address: 35 Cherry Hill Dr, # 37a, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-03-15
Posted by FDA: 2019-10-01
Terminated: 2024-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172058. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.