Medtronic, Temporary Pacing Lead System
Medical device recall Z-2200-2016. Published in FDA’s Enforcement Report on Jul 20, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 20, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 11697 (5523 OUS, 6174 US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
11697 (5523 OUS, 6174 US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 6416 Lot Number List: All Lots manufactured after 01May2014 as of 23May2016. Expiration dates through 12 April 2018. AAG102212F AAG127214F AAG154212F AAG177226F AHH123209F AHH167209F AAG102219F AAG128219F AAG154219F AAG177229F…
Every code shown here, 1,997 characters
Model 6416 Lot Number List: All Lots manufactured after 01May2014 as of 23May2016. Expiration dates through 12 April 2018. AAG102212F AAG127214F AAG154212F AAG177226F AHH123209F AHH167209F AAG102219F AAG128219F AAG154219F AAG177229F AHH124209F AHH168208F AAG103213F AAG129214F AAG155210F AAG178227F AHH125207F AHH169209F AAG104212F AAG130210F AAG156210F AAG178230F AHH126209F AHH170208F AAG104219F AAG130213F AAG156213F AAG179228F AHH127209F AHH171209F AAG105210F AAG131212F AAG157212F AAG179231F AHH128209F AHH172207F AAG105213F AAG131219F AAG157219F AAG180227F AHH129209F AHH173208F AAG106219F AAG132213F AAG158212F AAG180230F AHH130209F AHH174209F AAG107210F AAG133211F AAG158219F AAG181228F AHH131207F AHH175208F AAG107213F AAG133214F AAG159214F AAG181231F AHH132209F AHH176208F AAG108211F AAG134214F AAG160211F AAG182226F AHH133208F AHH177209F AAG108214F AAG135219F AAG160214F AAG182229F AHH134209F AHH178208F AAG109219F AAG136211F AAG161210F AAG183230F AHH135209F AHH179209F AAG110211F AAG136214F AAG161213F AAG184231F AHH136207F AHH180209F AAG111210F AAG137211F AAG162210F AAG185230F AHH137208F AHH181207F AAG112212F AAG137214F AAG162213F AAG186231F AHH138207F AHH182207F AAG112219F AAG138210F AAG163212F AAG187229F AHH139209F AHH183209F AAG113211F AAG138213F AAG163219F AAG188229F AHH140208F AHH184209F AAG113214F AAG139212F AAG164210F AAG189230F AHH141209F AHH185209F AAG114219F AAG139219F AAG164213F AAG190229F AHH142208F AHH186209F AAG115212F AAG140210F AAG165212F AAG191230F AHH143208F AHH187209F AAG115219F AAG140213F AAG165219F AAG192230F AHH144209F AHH188209F AAG116210F AAG141211F AAG166211F AAG193231F AHH145207F AHH189207F AAG116213F AAG141214F AAG166214F AAG194229F AHH146207F AHH190209F AAG117211F AAG142210F AAG167212F AAG195231F AHH147208F AHH191209F AAG117214F AAG142213F AAG167219F AAG196230F AHH148208F AHH192209F AAG118212F AAG143210F AAG168211F AAG197231F AHH149209F AHH192290F AAG118219F AAG143213F AAG168214F AHH105208F AHH150209F AHH193207F AAG119211F AAG144211F…
FDA’s list runs to 3,030 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Guam
- US Virgin Islands
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 16, 2016.
- FDA classified it on Jul 12, 2016.
- FDA’s Enforcement Report published it on Jul 20, 2016.
- FDA terminated it on Feb 13, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., Cardiac Rhythm and Heart Failure, of Mounds View, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,030 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.