FDA Device recall Z-0393-2017
NRG Transseptal Needle and NRG RF Transseptal Kit
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of NRG Transseptal Needle and NRG RF Transseptal Kit by Baylis Medical, citing 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 Transs….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0393-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-11 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baylis Medical |
| Distribution | n/a |
Product
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.
Reason
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.
Identifiers
| code_info | Lot numbers: NGFA240216 NGFC041115 NGFH211215 NGFA071015 NGFA151215 NGFB021115 NGFB090216 NGFB090616 NGFB101115…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 NGF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0393-2017%22
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