NRG Transseptal Needle and NRG RF Transseptal Kit
Medical device recall Z-0393-2017. Published in FDA’s Enforcement Report on Nov 16, 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 Nov 16, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 28,093 units 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?
The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart.
28,093 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot numbers: NGFA240216 NGFC041115 NGFH211215 NGFA071015 NGFA151215 NGFB021115 NGFB090216 NGFB090616 NGFB101115 NGFB220216 NGFB231115 NGFB281015 NGFC110416 NGFC120116 NGFC180416 NGFC211015 NGFC250116 NGFC301115 NGFD030616 NGFD080716…
Every code shown here, 1,993 characters
Lot numbers: NGFA240216 NGFC041115 NGFH211215 NGFA071015 NGFA151215 NGFB021115 NGFB090216 NGFB090616 NGFB101115 NGFB220216 NGFB231115 NGFB281015 NGFC110416 NGFC120116 NGFC180416 NGFC211015 NGFC250116 NGFC301115 NGFD030616 NGFD080716 NGFD091215 NGFD171115 NGFD250416 NGFE020216 NGFE090516 NGFE200116 NGFE240516 NGFF180716 NGFF211215 NGFH210316 NGFH290416 NGFI120216 NGFI270616 NGFA211015 NGFB111115 NGFB120116 NGFB140316 NGFB200616 NGFB271015 NGFC090516 NGFC161115 NGFC211215 NGFD021115 NGFD081215 NGFD160516 NGFE050116 NGFE090216 NGFE120216 NGFE290416 NGFF220216 NGFF231115 NGFF250416 NGFF270616 NGFF301115 NGFG240316 NGFG260116 NGFG300516 NGFH240516 NGFH290216 NGFI020216 NGFI210316 NGFD220216 NGFF050116 NGFA250116 NGFA240516 NGFD111115 NGFF180416 NGFH140316 NGFH151215 NGFI090616 NGFA241215 NGFB041115 NGFB070316 NGFC020216 NGFC060116 NGFC080816 NGFC120216 NGFC290416 NGFD110116 NGFD210316 NGFE200616 NGFG151215 NGFI250416 NGFB300415 NGFD040915 NGFG140715 NGFB301115 NGFA020316 NGFA030616 NGFA081215 NGFA120216 NGFA211215 NGFA270616 NGFB110116 NGFC071015 NGFC090616 NGFC240316 NGFC240516 NGFD090516 NGFD260116 NGFE040416 NGFE250416 NGFE300616 NGFF070316 NGFF110416 NGFF140316 NGFG180416 NGFJ290416 NGFA081015 NGFA210316 NGFA210616 NGFA240316 NGFA271015 NGFA301115 NGFA310316 NGFB020216 NGFB020316 NGFB030616 NGFB050516 NGFB080716 NGFB090516 NGFB120816 NGFB161115 NGFB270616 NGFB300616 NGFC151215 NGFC160516 NGFC300516 NGFD120216 NGFE020816 NGFE070316 NGFE190116 NGFF290216 NGFG040416 NGFG050116 NGFG140316 NGFG290416 NGFH110416 NGFH180716 NGFI180416 NGFI290416 NGFB180716 NGFB081215 NGFB171115 NGFB210316 NGFB240516 NGFC151015 NGFF190116 NGFF240316 NGFG090616 NGFI110416 NGFA021115 NGFA050516 NGFA090216 NGFA090516 NGFA160516 NGFA161115 NGFA300616 NGFC030616 NGFC110116 NGFD020816 NGFE180416 NGFF151215 NGFG151015 NGFH040416 NGFH090616 NGFJ240316 NGFJ290216 NGFA071215 NGFA190516 NGFB071015 NGFB200116 NGFB290216 NGFD271015 NGFF020216 NGFH180416 NGFH300516 NGFA101115 NGFB081015 NGFB091215…
FDA’s list runs to 2,564 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, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.
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?
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 Oct 11, 2016.
- FDA classified it on Nov 10, 2016.
- FDA’s Enforcement Report published it on Nov 16, 2016.
- FDA terminated it on Jul 10, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Baylis Medical Corp *, of Montreal, Canada.
- 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 2,564 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
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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.