UniD curve F ablation catheters recalled after tip detachment from packaging
Abbott is recalling 1,960 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve F configuration after becoming aware of tip detachment events during removal from the packaging.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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, UniD Curve F, REF A-TFSE-F, are being recalled.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The recall covers 1,960 units carrying GTIN 05415067034670, across batch numbers including 8894357, 8917490, 8984945, 10061309, 10061314, 10061316 and 10061317. 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, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
- Manufacturer
- Abbott
- Affected units
- 1,960
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 05415067034670
- Batch Numbers: 8894357
- 8917490
- 8984945
- 10061309
- 10061314
- 10061316
- 10061317
- 10084510
- 10084518
- 10089968
- 10089971
- 10099711
- 10132013
- 10132015
- 10132017
- 10217367
- 10360478
- 10360488
- 10371567
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Abbott under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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