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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81595

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

Open FDA event record

Event summary

Timeline bucket
November 15, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Covidien LLC

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

3 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 3

Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

Z-0625-2019
Recall number
Z-0625-2019
Initiated
November 15, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Covidien LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

Code information

GTIN Number - 10884521706606 Lot Numbers- S7HG007KX S7HG008KX S7HG009KX S7HG032LX S7HG033LX S7HG034LX S7JG008LX S7JG009X S7JG012X S7KG012LX S7KG038QX S7LG009X S7MG010LX S7MG019X S8BG004X S8BG005X S8CG002X S8DG001X S8DG026X S8EG004X

Distribution pattern

US Nationwide

device · product 2 of 3

Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

Z-0626-2019
Recall number
Z-0626-2019
Initiated
November 15, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Covidien LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

Code information

GTIN Number - 10884521706583 Lot Numbers- S7HG002X S7HG003X S7HG005KX S7HG006KX S7HG022LX S7HG023LX S7HG024LX S7HG025LX S7HG029LX S7HG040X S7HG041X S7HG045X S7HG049X S7JG007X S7JG011X S7JG033LX S7JG034X S7JG035X S7JG041LX S7JG042LX S7JG043LX S7JG044LX S7JG045LX S7JG046LX S7JG047LX S7KG023LX S7KG029X S7KG033X S7KG039X S7KG040X S7KG042X S7LG001X S7LG002X S7LG006X S7LG011X S7LG012X S7MG008LX S7MG009LX S7MG011X S7MG012X S7MG014X S7MG018X S7MG020X S7MG021X S7MG022PX S7MG023PX S7MG024X S7MG025X S7MG026X S8AG001X S8AG002X S8AG011X S8AG013X S8CG004X S8CG010X S8CG017X S8CG019PX S8CG022PX S8CG025X S8DG014LX S8DG015LX S8DG016LX S8DG017LX S8DG018LX S8DG024X S8DG027X S8EG005X S8EG009X S8EG010X S8EG011X

Distribution pattern

US Nationwide

device · product 3 of 3

Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

Z-0627-2019
Recall number
Z-0627-2019
Initiated
November 15, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Covidien LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

Code information

GTIN Number - 10884521706590 Lot Numbers- S7HG001PX S7HG004KX S7HG010KX S7HG011KX S7HG012KX S7HG030LX S7HG031LX S7HG035LX S7HG039LX S7HG042LX S7HG043X S7JG006X S7JG010X S7JG013X S7JG014X S7KG008LX S7KG009LX S7KG010LX S7KG041X S7KG043X S7LG003X S7LG004X S7MG003X S7MG004LX S7MG017PX S7MG029X S8BG001X S8BG002X S8BG006X S8CG001X S8CG008LX S8CG009X S8CG018X S8CG023X S8DG019LX S8DG020LX S8DG021LX S8DG022LX S8DG023X S8DG025X

Distribution pattern

US Nationwide