NRG Transseptal Needle and NRG RF Transseptal Kit — Class II medical device recall Z-0393-2017
Terminated recall by Baylis Medical Corp *, reported 2016-11-16. The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the pos
| Recall number | Z-0393-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baylis Medical Corp *, Montreal, Canada |
| Recall initiated | 2016-10-11 |
| Classified | 2016-11-10 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2017-07-10 |
| Countries outside the US | AE, CA, CL, DE, ES, FR, GB, HK, IE, IT, MX, NL |
| Quantity | 28,093 units |
| Lot numbers | NGFA020316, NGFA021115, NGFA030616, NGFA050516, NGFA071015, NGFA071215, NGFA081015, NGFA081215, NGFA090216, NGFA090516, NGFA101115, NGFA120216, NGFA151215, NGFA160516, NGFA161115, NGFA190116, NGFA190516, NGFA210316, NGFA210616, NGFA211015, NGFA211215, NGFA240216, NGFA240316, NGFA240516, NGFA241215, NGFA250116, NGFA270616, NGFA271015, NGFA300415, NGFA300616, NGFA301115, NGFA310316, NGFB020216, NGFB020316, NGFB021115, NGFB030616, NGFB041115, NGFB050516, NGFB070316, NGFB071015 and 192 more |
| Model 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, NRG-E-HF-71-C0 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0393-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.