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Abbott Recall 89872

Description: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.

Abbott Recall 89872 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0956-2022
Event ID89872
Event DescriptionAbbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.
Quantity2,134 devices
Recall ReasonDevices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Device Classification20220427
Device Code InfoLot numbers: 8162700, 8164687, 8164730, 8172360, 8173365, 8173840, 8175413, 8177068, 8177349, 8177442, 8179358, 8179499, 8180723, 8180900, 8181043, 8182658, 8183581, 8183595, 8184393, 8184739, 8184817, 8186470, 8186747, 8186860, 8188124, 8188351, 8188844, 8190306, 8190438, 8191524, 8192181, 8192250, 8194325, 8195968, 8196343, 8196367, and 8197913. UDI (01)05415067027641(17)230331(10)xxxxxxx (lot number).
Center Classification Date20220419
Recall Initiation Date20220324
Recalling FirmAbbott
Initial Notification Letter
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