Percutaneous Atrial Catheter Kit
Cardiovascular · 21 CFR 870.1250
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
67 adverse event reports on file
- VersaCross Access SolutionJul 27, 2026InjuryBoston Scientific Corporation2124215-2026-40072
- VERSACROSS CONNECT LAAC ACCESS SOLUTIONJul 16, 2026MalfunctionBoston Scientific Corporation2124215-2026-38239
- VERSACROSS CONNECT LAAC ACCESS SOLUTIONJul 12, 2026MalfunctionBoston Scientific Corporation2124215-2026-37290
- VERSACROSS CONNECT LAAC ACCESS SOLUTIONJul 12, 2026MalfunctionBoston Scientific Corporation2124215-2026-37295
- VERSACROSS CONNECT LAAC ACCESS SOLUTIONJul 8, 2026InjuryBoston Scientific Corporation2124215-2026-36547
- VERSACROSS ACCESS SOLUTIONJul 6, 2026DeathBoston Scientific Corporation2124215-2026-35908
- VersaCross Connect LAAC Access SolutionJul 6, 2026InjuryBoston Scientific Corporation2124215-2026-36133
- VersaCross Connect LAAC Access SolutionJul 3, 2026InjuryBaylis Medicale Cie Inc2124215-2026-35806
- ARROW RA CATH SET: 20 GA X 1-3/4INJul 2, 2026InjuryArrow International Llc9680794-2026-00508
- VERSACROSS CONNECT LAAC ACCESS SOLUTIONJul 1, 2026InjuryBoston Scientific Corporation2124215-2026-35349
Event type breakdown
Recalls
2 recall events for this product code
- ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2390-2026 · View FDA record ↗ - ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2391-2026 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Teleflex Llc (nadc)
Olive Branch, MS, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Sterigenics U.s., Llc
Charlotte, NC, US
Teleflex Medical Llc
Morrisville, NC, US
Corvia Medical, Inc.
Tewksbury, MA, US
Boston Scientific Corporation
Cartago, CR
Isomedix Operations Inc.
Northborough, MA, US
Boston Scientific Corporation
Saint Paul, MN, US
Isomedix Operations Inc
El Paso, TX, US
Vygon Mfg
DOVER, NH, US
Cardinal Health 200, Llc
El Paso, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Arrow International, Llc (subsidiary Of Teleflex Incorporated)
Wyomissing, PA, US
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Boston Scientific Corporation
El Coyol Alajuela, CR
Cardinal Health 200, Llc
Waukegan, IL, US
Boston Scientific Corporation
Coventry, RI, US
Vygon Usa
Lansdale, PA, US
Boston Scientific Corporation
Mississauga Ontario, CA
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.