Curve F-J ablation catheters recalled after tip detachment during unpacking
Abbott is recalling 11,810 TactiFlex Sensor Enabled Ablation Catheters in the F-J curve 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: Tip detachment events during catheter removal from the packaging. The notice does not report any illnesses, injuries or deaths. The agency classified it as Class I, which is scored Severe on that classification alone; Critical is reserved for recalls where a death or serious injury was reported. The notice states: "Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging."
Plain-English summary
TactiFlex Sensor Enabled Ablation Catheters, 8F, 115 cm, BiD Curve F-J, REF A-TFSE-FJ, are being recalled.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The recall covers 11,810 units carrying GTIN 05415067034618, across batch numbers including 10093213, 10093588, 10095366, 10096269, 10118676, 10131389 and 10151333. 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, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
- Manufacturer
- Abbott
- Affected units
- 11,810
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 05415067034618
- Batch Numbers: 10093213
- 10093588
- 10095366
- 10096269
- 10118676
- 10131389
- 10151333
- 10180969
- 10286877
- 10315661
- 10317649
- 10329929
- 10332297
- 10344177
- 10350400
- 10360030
- 10374171
- 10375844
- 10418954
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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