Z-2301-2012Class II

DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA...

Name: Z-2301-2012 DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA...
Creator: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Published: 2012-08-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-08-01 / Terminated / root cause: manufacturing process

FDA source

Nellcor Puritan Bennett Inc. (dba Covidien LP) began a recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used... on 2012-08-01. FDA classified it as Class II and gives the reason as "Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2301-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-01
Posted: 2012-08-29
Terminated: 2013-09-06
Recalling firm: Medtronic, Inc.
Product: DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 6, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine and discontinue use of the device; immediately advise all DGPHP RFA High-Power single use grounding pads and Cool-tip RF Electrode kit users of this recall; complete and return the attached Recalled Product Return Form in its entirety via fax to (800) 895-6140; return affected product to Covidien Attn: Field Returns Department, 195 McDermott Road, North Haven, CT 06473; if purchased directly from Covidien include completed form via fax or by email to : [email protected]; if purchased from distributor complete form and contact your Distributor directly (completed form and all affected units must be returned through the Distributor); and reply to Covidien WHETHER OR NOT you have affect product at your site. If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance, Monday through Friday, 8:30-5:00, directly at 203-492-5232.
Quantity in commerce: 184,934 units
Distribution: Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
Product codes and lots: ACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 168853 through, 209457X; ACT1507, 168576 through, 209455X; SWCT1530, 170383 through, 210057X; ACT1510, 170882 through , 207901X; SWCT15303, 169683 through, 207900X; ACT1520, 168571 through, 210054X; SWCT1540, 170384 through, 197330; ACT1530, 169419 through, 209547X; SWCT20303, 191407 through, 191407; ACT2020, 168854 through, 210720X; SWCT2303, 195745 through, 195745; ACT2030, 168574 through, 209453X; SWCT2530, 205456 through, 205456; ACT2530, 169684 through, 209599X; SWCT25303, 177906 through, 213729X; ACTC1025, 171300 through, 208194X; SWCT2540, 191404 through, 205455 DGPHP, 162732 through, 214867X.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2301-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2301-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-29

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)