Medtronic InSync III
Medical device recall Z-0342-2016. Published in FDA’s Enforcement Report on Dec 9, 2015.
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 Dec 9, 2015. 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
- 96,787 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?
Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
96,787, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Manufactured Serial Numbers PKF100010H PKF100011H PKF100012H PKF100013H PKF100014H PKF100015H PKF100016H PKF100018H PKF100019H PKF100020H PKF100021H PKF100022H PKF100023H PKF100024H PKF100025H PKF100026H PKF100027H PKF100028H PKF100029H…
Every code shown here, 1,997 characters
Manufactured Serial Numbers PKF100010H PKF100011H PKF100012H PKF100013H PKF100014H PKF100015H PKF100016H PKF100018H PKF100019H PKF100020H PKF100021H PKF100022H PKF100023H PKF100024H PKF100025H PKF100026H PKF100027H PKF100028H PKF100029H PKF100030H PKF100031H PKF100032H PKF100033H PKF100034H PKF100035H PKF100036H PKF100037H PKF100038H PKF100039H PKF100040H PKF100041H PKF100042H PKF100043H PKF100044H PKF100045H PKF100046H PKF100047H PKF100048H PKF100049H PKF100050H PKF100051H PKF100052H PKF100053H PKF100054H PKF100055H PKF100056H PKF100057H PKF100058H PKF100059H PKF100060H PKF100061H PKF100062H PKF100063H PKF100064H PKF100065H PKF100066H PKF100067H PKF100068H PKF100069H PKF100070H PKF100071H PKF100072H PKF100073H PKF100074H PKF100075H PKF100076H PKF100077H PKF100078H PKF100079H PKF100080H PKF100081H PKF100082H PKF100083H PKF100084H PKF100085H PKF100086H PKF100087H PKF100088H PKF100089H PKF100090H PKF100091H PKF100092H PKF100093H PKF100094H PKF100095H PKF100096H PKF100097H PKF100098H PKF100099H PKF100100H PKF100101H PKF100102H PKF100103H PKF100104H PKF100105H PKF100106H PKF100107H PKF100108H PKF100109H PKF100110H PKF100111H PKF100112H PKF100113H PKF100114H PKF100115H PKF100116H PKF100117H PKF100118H PKF100119H PKF100120H PKF100121H PKF100122H PKF100123H PKF100124H PKF100125H PKF100126H PKF100127H PKF100128H PKF100129H PKF100130H PKF100131H PKF100132H PKF100133H PKF100134H PKF100135H PKF100136H PKF100137H PKF100138H PKF100139H PKF100140H PKF100141H PKF100142H PKF100143H PKF100144H PKF100145H PKF100146H PKF100147H PKF100148H PKF100149H PKF100150H PKF100151H PKF100152H PKF100153H PKF100154H PKF100155H PKF100156H PKF100157H PKF100158H PKF100159H PKF100160H PKF100161H PKF100162H PKF100163H PKF100164H PKF100165H PKF100166H PKF100167H PKF100168H PKF100169H PKF100170H PKF100171H PKF100172H PKF100173H PKF100174H PKF100175H PKF100176H PKF100177H PKF100178H PKF100179H PKF100180H PKF100181H PKF100182H PKF100183H PKF100184H PKF100185H PKF100186H PKF100187H PKF100188H PKF100189H…
FDA’s list runs to 1,212,781 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 - USA (nationwide) including Puerto Rico and to Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary , India, Indonesia, Iran, Ireland, Israel, Italy, Japan Jordan, Kazakhstan, Kenya, Kuwait, Korea, Latvia, Luxembourg, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius , Mexico, Morocco, Netherlands, New Zealand, Norway,Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.
The states and territories these words name
- Georgia
- Puerto Rico
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 Nov 9, 2015.
- FDA classified it on Nov 27, 2015.
- FDA’s Enforcement Report published it on Dec 9, 2015.
- FDA terminated it on Aug 24, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., of Saint Paul, 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 1,212,781 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.