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TSP Crosser Transseptal Access System
TRANSSEPTAL SOLUTIONS LTD · Model TSUS001 · UDI-DI 07290017811017
DYB
Prescription
10
510(k) clearances
41,188
Adverse events (1,361 deaths)
389
Recalls
275
Facilities
Description
The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-15 | Terumo Medical Corporation | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.