[pending] TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac
Pending LLM rewrite. Source: FDA_DEVICE Z-0110-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The recalled product
- Product
- TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
- Manufacturer
- Abbott
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 05415067034557
- Batch Numbers: 8843948
- 8855039
- 8906316
- 8913730
- 8921154
- 8922146
- 8933195
- 8947323
- 8949324
- 8958968
- 8959452
- 8960986
- 8961409
- 8963254
- 8965484
- 8965486
- 8991236
- 8993365
- 9001917
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27