Endrys G19261Recalls & reported problems
Cook Incorporated · Transseptal Needle with Catheter · Class 2
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 8, 2021Terminated
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.
Z-0223-2022 · Root cause: Nonconforming Material/Component · FDA record ↗
Other Trocar devices
- BRK™ G407208St. Jude Medical Cardiovascular Division · Trocar3 deaths75 reports
- BRK™ 407200St. Jude Medical Cardiovascular Division · Trocar4 deaths71 reports
- NA EP003994SMedtronic, Inc. · Trocar60 reports
- Cook G02364Cook Incorporated · Trocar1 recall5 reports
- HeartSpan® 00884450489345Merit Medical Systems, Inc. · Trocar1 recall1 death2 reports
- Cook G01377Cook Incorporated · Trocar1 recall2 reports
- HeartSpan® 00884450489369Merit Medical Systems, Inc. · Trocar1 recall0 reports
- BRK-1™ G407209St. Jude Medical Cardiovascular Division · Trocar4 deaths50 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.