Patient Connector
Medical device recall Z-2506-2020. Published in FDA’s Enforcement Report on Jul 15, 2020.
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 15, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 1025 devices 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?
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management”, Atrial Lead Position Check”, EffectivCRT” algorithms, and AdaptivCRT”). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Patient Connector, Model Number 24967
1025 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
serial numbers: RFA001342A RFA001412A RFA001748A RFA001760A RFA001802A RFA001845A RFA001868A RFA001885A RFA002011A RFA002039A RFA002152A RFA003642A RFA003644A RFA003652A RFA003658A RFA003669A RFA003671A RFA003673A RFA003677A RFA003684A…
Every code shown here, 1,996 characters
serial numbers: RFA001342A RFA001412A RFA001748A RFA001760A RFA001802A RFA001845A RFA001868A RFA001885A RFA002011A RFA002039A RFA002152A RFA003642A RFA003644A RFA003652A RFA003658A RFA003669A RFA003671A RFA003673A RFA003677A RFA003684A RFA003690A RFA003691A RFA003692A RFA003703A RFA003704A RFA003705A RFA004075A RFA004079A RFA004082A RFA004208A RFA004218A RFA004232A RFA004277A RFA004386A RFA004390A RFA004391A RFA004681A RFA004706A RFA005006A RFA005009A RFA005011A RFA005023A RFA005025A RFA005028A RFA005029A RFA005049A RFA005079A RFA005081A RFA005093A RFA005095A RFA005097A RFA005103A RFA005105A RFA005125A RFA005249A RFA005989A RFA006832A RFA008087A RFA008119A RFA008908A RFA009323A RFA010721A RFA010722A RFA010895A RFA011167A RFA011196A RFA011348A RFA011359A RFA011456A RFA011493A RFA011519A RFA011725A RFA011764A RFA011770A RFA011774A RFA011780A RFA011795A RFA011796A RFA011797A RFA011824A RFA011827A RFA011840A RFA011846A RFA011859A RFA011860A RFA011862A RFA011872A RFA011879A RFA011885A RFA011898A RFA011919A RFA011927A RFA011928A RFA011931A RFA011933A RFA011938A RFA011952A RFA011958A RFA011959A RFA011966A RFA011973A RFA011976A RFA011978A RFA012031A RFA012034A RFA012048A RFA012124A RFA012126A RFA012129A RFA012133A RFA012149A RFA012155A RFA012158A RFA012159A RFA012160A RFA012164A RFA012167A RFA012174A RFA012176A RFA012188A RFA012198A RFA012199A RFA012200A RFA012201A RFA012202A RFA012205A RFA012223A RFA012227A RFA012230A RFA012233A RFA012234A RFA012235A RFA012260A RFA012273A RFA012274A RFA012276A RFA012277A RFA012279A RFA012290A RFA012301A RFA012309A RFA012328A RFA012369A RFA012411A RFA012412A RFA012423A RFA012433A RFA012441A RFA012449A RFA012450A RFA012469A RFA012476A RFA012496A RFA012506A RFA012521A RFA012527A RFA012530A RFA012531A RFA012532A RFA012535A RFA012539A RFA012542A RFA012554A RFA012556A RFA012562A RFA012571A RFA012580A RFA012586A RFA012587A RFA012590A RFA012598A RFA012603A RFA012611A RFA012624A RFA012633A RFA012636A RFA012639A RFA012643A RFA012647A RFA012654A…
FDA’s list runs to 11,290 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
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 4, 2020.
- FDA classified it on Jul 5, 2020.
- FDA’s Enforcement Report published it on Jul 15, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), 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 11,290 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.