Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
Check against the official notice below — it lists the full affected range.
Cook Inc. is recalling transseptal needles and obturators (medical devices used in cardiac procedures) because the needles may contain rust on their interior and/or exterior surfaces that users cannot detect. If an affected product is used during a procedure, potential complications range from extended procedure time to inflammatory reactions, and in severe cases may include systemic reactions that could result in permanent impairment or death.
Approximately 31,502 units were distributed in the United States and 30,166 units were distributed internationally. The recall affects multiple lot numbers manufactured between October 2021 and December 2021. The source document does not specify what action affected consumers or patients should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
Reason for recall: Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 31,502 US (30,166 OUS) Lot/code info: All Lots UDI: (01)00827002023642(17)211002(10)7322883 (01)00827002023642(17)211002(10)7322885 (01)00827002023642(17)211002(10)7322886 (01)00827002023642(17)211008(10)7344835 (01)00827002023642(17)211008(10)7344836 (01)00827002023642(17)211011(10)7350041 (01)00827002023642(17)211011(10)7350042 (01)00827002023642(17)211011(10)7350043 (01)00827002023642(17)211011(10)7350044 (01)00827002023642(17)211012(10)7354287 (01)00827002023642(17)211012(10)7354288 (01)00827002023642(17)211012(10)7354289 (01)00827002023659(17)211012(10)7354290 (01)00827002023659(17)211012(10)7354291 (01)00827002023642(17)211012(10)7354334 (01)00827002023642(17)211012(10)7354335 (01)00827002023642(17)211012(10)7354336 (01)00827002023642(17)211016(10)7363498 (01)00827002023642(17)211016(10)7363499 (01)00827002023642(17)211016(10)7363500 (01)00827002023642(17)211019(10)7370952 (01)00827002023642(17)211019(10)7370953 (01)00827002023642(17)211019(10)7370954 (01)00827002023642(17)211022(10)7380090 (01)00827002023642(17)211022(10)7380092 (01)00827002023659(17)211026(10)7390097 (01)00827002023642(17)211201(10)7484138 (01)00827002023642(17)211206(10)7493159 (01)00827002023642(17)211206(10)7493160 (01)00827002023642(17)211206(10)7493161 (01)00827002023642(17)211206(10)7493162 (01)00827002023642(17)211206(10)7493163 (01)00827002023642(17)211206(10)7493164 (01)00827002023642(17)211206(10)7493165 (01)00827002023642(17)211206(10)7493166 (01)00827002023642(17)211206(10)7493167 (01)00827002023642(17)211206(10)7493357 (01)00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.