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Terminated

Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtronic temporary external pacemakers.

FDA Recall Z-2200-2016 · Posted None

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure
Recall StatusTerminated
Product CodeLDF
Date Initiated2016-06-16
Date Terminated2018-02-13
Product Quantity11697 (5523 OUS, 6174 US)

Reason for Recall

This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a possible hazardous voltage.

Firm Action

Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter was addressed to Health Care Professional. The letter described the problem and the product involved in the recall. The letter described the "Customer Actions" which advised consignees to identify, quarantine and return affected product to Medtronic. Customers were instructed to complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and e-mail to [email protected]. For questions, please contact your Medtronic CRHF Sales Representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution. US nationwide, Albania, Algeria, Australia, Botswana, Bulgaria, Canada, Colombia, France, Gabon, Germany, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Kazakhstan, Macedonia, Mauritius, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, St Maarten, Sweden, Switzerland, Tajikistan, Turkey, Uganda, United Arab Emirates, United Kingdom, and US Virgin Islands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042190MODEL 6416 TEMPORARY PACING LEAD SYSTEMMedtronic Vascular · 2004-09-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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