Curve D-D ablation catheters recalled after tip detachment from packaging
Abbott is recalling 3,404 TactiFlex Sensor Enabled Ablation Catheters in the D-D curve after becoming aware of tip detachment events during removal from the packaging.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
TactiFlex Sensor Enabled Ablation Catheters, 8F, 115 cm, BiD Curve D-D, REF A-TFSE-DD, are being recalled.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The recall covers 3,404 units carrying GTIN 05415067034557, across batch numbers including 8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195 and 8947323. Distribution was worldwide. The FDA has classified the recall as Class I.
Electrophysiology labs should inspect the catheter before use and follow Abbott's instructions for affected batch numbers.
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
- Hazard
- tip-detachment
- device-defect
- ablation-catheter
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.
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