Z-1411-2021Class II

Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22...

Name: Z-1411-2021 Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22...
Creator: Covidien
Published: 2021-03-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-03-05 / Open, Classified / root cause: manufacturing process

FDA source

Covidien began a recall of Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094 on 2021-03-05. FDA classified it as Class II and gives the reason as "Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1411-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-05
Posted: 2021-04-12
Recalling firm: Medtronic, Inc.
Product: Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 3/10/2021, Medtronic issued an Urgent Medical Device Recall notices to customers. All consignees were notified by letter delivered via Federal Express and/or certified mail. The letter informs customers of the recall of specific item codes and production lots of Covidien Surgiwand" II Suction and Irrigation Device following reports from customers of foreign particles in the device tubing.
Quantity in commerce: 59,828 devices
Distribution: Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand, Singapore, Malaysia, Philippines, Bahamas, Brazil, Chile, El Salvador, Guatemala, Jamaica, Mexico, Panama, Peru, Puerto Rico, Trinidad And Tobago, Austria, Belgium, Bosnia And Herzegovina, Canary Islands, Cyprus, Denmark, Equatorial Guinea, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Kosovo, Kuwait, Lebanon, Mauritius, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, Spain, Swaziland, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.
Product codes and lots: UDI-Device Identifier (GTIN/UPN): 10884523000887, 20884523000884 UDI-Device Identifier (GTIN/UPN): 10884523000900, 20884523000907 UDI-Device Identifier (GTIN/UPN): 10884523000917, 20884523000914

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1411-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1411-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-12

Product code GEI

K961771Class IIAuto Suture SurgiwandUnited States Surgical, A Division of Tyco Healthc / cleared 1996-09-25

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)