Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
Reported: November 24, 2021 Initiated: October 8, 2021 #Z-0223-2022
Product Description
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 4789 (OUS only)
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle. Recalled by Cook Inc.. Units affected: 4789 (OUS only).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0223-2022.
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