Z-1467-2022Class II

TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine...

Name: Z-1467-2022 TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine...
Creator: Covidien Llc
Published: 2022-06-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-06-07 / Open, Classified / root cause: design

FDA source

Covidien Llc began a recall of TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808 on 2022-06-07. FDA classified it as Class II and gives the reason as "Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1467-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-07
Posted: 2022-07-26
Recalling firm: Medtronic, Inc.
Product: TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Product code: HIH Hysteroscope (And Accessories)
Reason for recall: Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic issued Urgent Medical Device Recall letter on 6/7/22 (Field Action #: FA1259) via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take: "Identify and quarantine all affected product. The enclosed Customer Notification DetailReport includes affected product for your facility. " Return all affected product in your inventory to Medtronic. a. Product purchased directly from Medtronic: [email protected] b. Product purchased through distributor: [email protected] " Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Complete the enclosed Customer Confirmation Form and email it to [email protected] " If you have questions or concerns regarding this recall, please contact Medtronic CustomerService at 800-854-3570.
Quantity in commerce: 33 units
Distribution: AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain
Product codes and lots: UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1467-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1467-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-26

Product code HIH

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)