Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89872

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 24, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Abbott

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0956-2022
Recall number
Z-0956-2022
Initiated
March 24, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Abbott
Quantity
2,134 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

Code information

Lot 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).

Distribution pattern

Worldwide 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.

device · product 2 of 2

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

Z-0957-2022
Recall number
Z-0957-2022
Initiated
March 24, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Abbott
Quantity
588 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

Code information

Lot numbers: 8181068, 8182131, 8198290, 8198350, 8200249, 8200300, 8201447, 8202313, 8203518, 8203835, 8203857, 8205760, and 8207547. UDI (01)05415067027634(17)230331(10)xxxxxxx (lot number).

Distribution pattern

Worldwide 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.

Field note

Send feedback

We'll only use this to respond to your feedback.